Deployment techniques for annuloplasty structure

ABSTRACT

A first part of an annuloplasty structure is anchored to an annulus of a valve of a heart by using a driver to screw a tissue-coupling element of a first anchor into a first site of the annulus, such that the tissue-coupling element enters cardiac tissue in a direction parallel to a central longitudinal axis of the driver through the distal end of the anchor driver. The same is subsequently done for second and third parts of the annuloplasty structure using second and third anchors at second and third sites of the annulus,  mutatis mutandis . Between anchors, the driver is retracted out of the heart. Subsequently, the valve is treated by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 15/474,632, filed Mar. 30, 2017, which is a continuation ofU.S. patent application Ser. No. 13/319,030, filed Dec. 16, 2011, nowU.S. Pat. No. 9,636,224, which is the US national phase of InternationalPatent Application PCT/IL2010/000358, filed May 4, 2010, which:

(a) is a continuation-in-part of and claims the priority from U.S.patent application Ser. No. 12/435,291 to Maisano et al., entitled,“Adjustable repair chords and spool mechanism therefor,” filed May 4,2009, now U.S. Pat. No. 8,147,542;

(b) is a continuation-in-part of and claims the priority from U.S.patent application Ser. No. 12/437,103 to Zipory et al., entitled,“Annuloplasty ring with intra-ring anchoring,” filed May 7, 2009, nowU.S. Pat. No. 8,715,342;

(c) is a continuation-in-part of and claims the priority from U.S.patent application Ser. No. 12/548,991 to Maisano et al., entitled,“Implantation of repair chords in the heart,” filed Aug. 27, 2009, nowU.S. Pat. No. 8,808,368;

(d) is a continuation-in-part of and claims the priority from U.S.patent application Ser. No. 12/689,635 to Zipory et al., entitled,“Over-wire rotation tool,” filed Jan. 19, 2010, now U.S. Pat. No.8,545,553; and

(e) is a continuation-in-part of and claims the priority from U.S.patent Ser. No. 12/689,693 to Hammer et al., entitled, “Deploymenttechniques for annuloplasty ring,” filed Jan. 19, 2010, now U.S. Pat.8,911,494.

All of the above-mentioned applications are assigned to the assignee ofthe present application and are incorporated herein by reference.

FIELD OF THE APPLICATION

Some applications of the present invention relate in general to valverepair, and more specifically to repair of an atrioventricular valve ofa patient.

BACKGROUND OF THE APPLICATION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

US Patent Application Publication 2007/0080188 to Spence et al.describes systems and methods for securing tissue including the annulusof a mitral valve. The systems and methods may employ catheter basedtechniques and devices to plicate tissue and perform an annuloplasty.Magnets may be used for guidance in deploying fasteners from a catheter.The fasteners are cinched with a flexible tensile member.

U.S. Pat. 6,619,291 to Hlavka et al. describes a minimally invasivemethod of performing annuloplasty. A method for performing a procedureon a mitral valve of a heart includes inserting an implant into a leftventricle and orienting the implant in the left ventricle substantiallybelow the mitral valve. The implant and tissue around the mitral valveare connected and tension is provided to the implant, in oneapplication, in order to substantially reduce an arc length associatedwith the mitral valve. In another application, the implant is insertedinto the left ventricle through the aorta and the aortic valve.

US Patent Application Publication 2006/0241656 to Starksen et al.describes devices, systems and methods for facilitating positioning of acardiac valve annulus treatment device, thus enhancing treatment of theannulus. Methods generally involve advancing an anchor delivery devicethrough vasculature of the patient to a location in the heart fortreating the valve annulus, contacting the anchor delivery device with alength of the valve annulus, delivering a plurality of coupled anchorsfrom the anchor delivery device to secure the anchors to the annulus,and drawing the anchors together to circumferentially tighten the valveannulus. Devices generally include an elongate catheter having at leastone tensioning member and at least one tensioning actuator for deforminga distal portion of the catheter to help it conform to a valve annulus.The catheter device may be used to navigate a subannular space below amitral valve to facilitate positioning of an anchor delivery device.

US Patent Application Publication 2006/0025787 to Morales et al.describes methods and devices that provide constriction of a heart valveannulus to treat cardiac valve regurgitation and other conditions.Applications typically include a device for attaching a cinching ortightening apparatus to a heart valve annulus to reduce thecircumference of the annulus, thus reducing valve regurgitation.Tightening devices may include multiple tethered clips, multipleuntethered crimping clips, stabilizing devices, visualization devices,and the like. In one application, a plurality of tethered clips issecured circumferentially to a valve annulus, and the tether couplingthe clips is cinched to reduce the circumference of at least a portionof the annulus. Methods and devices may be used in open heart surgicalprocedures, minimally invasive procedures, catheter-based procedures,and/or procedures on beating hearts or stopped hearts.

U.S. Pat. No. 7,431,692 to Zollinger et al. describes an adjustablesupport pad for adjustably holding a tensioning line used to applytension to a body organ. The adjustable support pad can include alocking mechanism for preventing slidable movement of the tensioningelement in one or both directions. The locking mechanism may includespring-loaded locks, rotatable cam-like structures, and/or rotatablespool structures. The adjustable support pad may be formed from rigid,semi-rigid, and/or flexible materials, and may be formed to conform tothe outer surface of a body organ. The adjustable support pad can beconfigured to adjustably hold one or more separate tensioning lines, andto provide for independent adjustment of one or more tensioning lines orgroups thereof.

US Patent Application Publication 2007/0016287 to Cartledge et al.describes an implantable device for controlling shape and/or size of ananatomical structure or lumen. The implantable device has an adjustablemember configured to adjust the dimensions of the implantable device.The implantable device is housed in a catheter and insertable from aminimally invasive surgical entry. An adjustment tool actuates theadjustable member and provide for adjustment before, during or after theanatomical structure or lumen resumes near normal to normal physiologicfunction.

US Patent Application Publication 2004/0236419 to Milo describes methodsfor reconfiguring an atrioventricular heart valve that may use systemscomprising a partial or complete annuloplasty rings proportioned toreconfigure a heart valve that has become in some way incompetent, apair of trigonal sutures or implantable anchors, and a plurality ofstaples which may have pairs of legs that are sized and shaped forassociation with the ring at spaced locations along its length. Thesesystems permit relative axial movement between the staples and the ring,whereby a patient's heart valve can be reconfigured in a manner thatdoes not deter subtle shifting of the native valve components.Shape-memory alloy material staples may have legs with free ends thatinterlock following implantation. Annuloplasty rings may be complete orpartial and may be fenestrated. One alternative method routes a flexiblewire, preferably of shape-memory material, through the bights ofpre-implanted staples. Other alternative systems use linkers ofshape-memory material having hooked ends to interengage with staples orother implanted supports which, following implantation, decrease ineffective length and pull the staples or other supports toward oneanother so as to create desired curvature of the reconfigured valve.These linkers may be separate from the supports or may be integral withthem and may have a variety of shapes and forms. Various ones of thesesystems are described as being implanted non-invasively using a deliverycatheter.

US Patent Application Publication 2005/0171601 to Cosgrove et al.describes an annuloplasty repair segment and template for heart valveannulus repair. The elongate flexible template may form a distal part ofa holder that also has a proximal handle. Alternatively, the templatemay be releasably attached to a mandrel that slides within a deliverysheath, the template being released from the end of the sheath to enablemanipulation by a surgeon. A tether connecting the template and mandrelmay also be provided. The template may be elastic, temperatureresponsive, or multiple linked segments. The template may be alignedwith the handle and form a two- or three-dimensional curve out ofalignment with the handle such that the annuloplasty repair segmentattached thereto conforms to the curve. The template may be actively orpassively converted between its straight and curved positions. Thecombined holder and ring is especially suited for minimally-invasivesurgeries in which the combination is delivered to an implantation sitethrough a small access incision with or without a cannula, or through acatheter passed though the patient's vasculature.

The following patents and patent application publications may be ofinterest:

U.S. Pat. No. 5,306,296 to Wright et al.

U.S. Pat. No. 5,674,279 to Wright et al.

U.S. Pat. No. 5,961,539 to Northrup, III et al.

U.S. Pat. No. 6,524,338 to Gundry

U.S. Pat. No. 6,569,198 to Wilson et al.

U.S. Pat. No. 6,602,288 to Cosgrove et al.

U.S. Pat. No. 6,602,289 to Colvin et al.

U.S. Pat. No. 6,689,164 to Seguin

U.S. Pat. No. 6,702,826 to Liddicoat et al.

U.S. Pat. No. 6,718,985 to Hlavka et al.

U.S. Pat. No. 6,764,510 to Vidlund et al.

U.S. Pat. No. 7,004,176 to Lau

U.S. Pat. No. 7,101,395 to Tremulis et al.

U.S. Pat. No. 7,175,660 to Cartledge et al.

U.S. Pat. No. 7,186,262 to Saadat

US Patent Application Publication 2002/0087048 to Brock et al.

US Patent Application Publication 2002/0173841 to Ortiz et al.

US Patent Application Publication 2003/0050693 to Quijano et al.

US Patent Application Publication 2003/0167062 to Gambale et al.

US Patent Application Publication 2004/0024451 to Johnson et al.

US Patent Application Publication 2004/0122514 to Fogarty et al.

US Patent Application Publication 2004/0148021 to Cartledge et al.

US Patent Application Publication 2005/0055087 to Starksen

US Patent Application Publication 2005/0288781 to Moaddeb et al.

US Patent Application Publication 2006/0069429 to Spence et al.

US Patent Application Publication 2007/0051377 to Douk et al.

US Patent Application Publication 2007/0055206 to To et al.

US Patent Application Publication 2007/0162111 to Fukamachi et al.

US Patent Application Publication 2007/0255400 to Parravicini et al.

US Patent Application Publication 2008/0004697 to Lichtenstein et al.

PCT Publication WO 01/26586 to Seguin

PCT Publication WO 02/085251 to Hlavka et al.

PCT Publication WO 02/085252 to Hlavka et al.

PCT Publication WO 06/097931 to Gross et al.

PCT Publication WO 07/136783 to Cartledge et al.

PCT Publication WO 08/068756 to Gross et al.

The following articles may be of interest:

O'Reilly S et al., “Heart valve surgery pushes the envelope,” MedtechInsight 8(3): 73, 99-108 (2006)

Dieter R S, “Percutaneous valve repair: Update on mitral regurgitationand endovascular approaches to the mitral valve,” Applications inImaging, Cardiac Interventions, Supported by an educational grant fromAmersham Health pp. 11-14 (2003)

Swain C P et al., “An endoscopically deliverable tissue-transfixingdevice for securing biosensors in the gastrointestinal tract,”Gastrointestinal Endoscopy 40(6): 730-734 (1994)

Odell J A et al., “Early Results of a Simplified Method of Mitral ValveAnnuloplasty,” Circulation 92:150-154 (1995)

SUMMARY

In some applications of the present invention, an implant structure isprovided that comprises a contracting mechanism. The contractingmechanism comprises a rotatable structure, arranged such that rotationof the rotatable structure contracts the implant structure. The implantfurther comprises a longitudinal member, such as a wire, which iscoupled to the contracting mechanism. A rotation tool is provided forrotating the rotatable structure. The tool is configured to be guidedalong (e.g., over, alongside, or through) the longitudinal member, toengage the rotatable structure, and to rotate the rotatable structure inresponse to a rotational force applied to the tool.

In some applications of the present invention, the implant structurecomprises an adjustable partial annuloplasty ring for repairing adilated valve annulus of an atrioventricular valve, such as a mitralvalve. The annuloplasty ring comprises a flexible sleeve and a pluralityof anchors. An anchor deployment manipulator is advanced into a lumen ofthe sleeve, and, from within the lumen, deploys the anchors through awall of the sleeve and into cardiac tissue, thereby anchoring the sleevearound a portion of the valve annulus.

For some applications of the present invention, the anchors are deployedfrom a distal end of the manipulator while the distal end is positionedsuch that a central longitudinal axis through the distal end of themanipulator forms an angle with a surface of the cardiac tissue ofbetween about 45 and 90 degrees, e.g., between about 75 and 90 degrees,such as about 90 degrees. Typically, the anchors are deployed from thedistal end of the manipulator into the cardiac tissue in a directionparallel to the central longitudinal axis through the distal end of themanipulator.

In some applications of the present invention, the anchors are deployedfrom the left atrium into the upper region of the ventricular wall nearthe atrium, tissue of which generally provides more secure anchoringthan does the atrial wall. The above-mentioned angle of deploymentenables such deployment into the upper region of the ventricular wall.

In some applications of the present invention, the anchor deploymentmanipulator comprises a steerable outer tube in which is positioned ananchor driver having an elongated, flexible shaft. Rotation of theanchor driver screws the anchors into the cardiac tissue. The anchorsmay, for example, be helical in shape.

For some applications, the plurality of anchors are applied using themanipulator by loading a first one of the anchors onto the anchordriver, and deploying the anchor into the cardiac tissue. The anchordriver is withdrawn from the body of the subject, and a second one ofthe anchors is loaded onto the anchor driver. The anchor driver isreintroduced into the sleeve of the annuloplasty ring, and the secondanchor is deployed. These steps are repeated until all of the anchorshave been deployed. Alternatively, the anchor driver is configured tosimultaneously hold a plurality of anchors, and to deploy them one at atime.

Typically, the manipulator is gradually withdrawn in a proximaldirection during the anchoring procedure as anchors are deployed. Thefirst anchor is thus deployed most distally in the sleeve (generally ator within a few millimeters of the distal tip of the sleeve), and eachsubsequent anchor is deployed more proximally.

For some applications, the annuloplasty ring is typically configured tobe placed only partially around the valve annulus (e.g., to assume aC-shape), and, once anchored in place, to be contracted so as tocircumferentially tighten the valve annulus. To this end, theannuloplasty ring may comprise a flexible contracting member such as awire, which is typically positioned within the lumen of the sleeve.

For some applications, the contracting mechanism comprises a spool towhich a first end of the contracting member is coupled. The spool ispositioned in a vicinity of either the proximal or the distal end of thesleeve, or the spool is positioned at any suitable location between theproximal and distal ends of the sleeve. A second end of the contractingmember is coupled to the sleeve in a vicinity of the end of the sleeveopposite the end to which the spool is positioned. Rotation of the spoolwinds a portion of the contracting member around the spool, therebycontracting the implant structure. For some applications, thecontracting mechanism comprises a housing that houses the spool, and therotation tool is configured to engage and rotate the spool with respectto the housing. For some applications, the rotation tool comprises atube, which is configured to be passed over the longitudinal membercoupled to the contracting mechanism, and to engage the housing, suchthat the housing is held rotationally stationary when the tube is heldrotationally stationary.

For some applications, the longitudinal member is removably coupled tothe contracting mechanism, e.g., to the rotatable structure of thecontracting mechanism. For example, a distal portion of the longitudinalmember may be shaped so as to define a screw thread, and the contractingmechanism may shaped so as to define a threaded opening, into which thedistal portion of the longitudinal member is screwed so as to removablycoupled the longitudinal member to the contracting mechanism.

For some applications, the rotation tool comprises a first tube, whichis configured to pass over the longitudinal member. Rotation of the tubedecouples the longitudinal member from the contracting mechanism. Forsome applications, the rotation tool further comprises a second tube,which is configured to pass over the first tube. The second tube engagesthe rotatable structure, such that rotation of the second tube rotatesthe rotatable structure.

In some applications of the present invention, a rotation handle isprovided. A longitudinal member, such as the proximal end of thelongitudinal member coupled to the contracting mechanism, is passed atleast partially through the rotation handle. The rotation handlecomprises (a) a first-tube rotation knob, which is coupled to the firsttube, such that rotation of the first-tube rotation knob rotates thefirst tube, (b) a second-tube rotation knob, which is coupled to thesecond tube, such that rotation of the second-tube rotation knob rotatesthe second tube, and (c) a control knob. When in a first position, thecontrol knob engages both first-tube and second-tube rotation knobs.When in a second position, the control knob engages the second-tuberotation knob but not the first-tube rotation knob. For someapplications, when in the first position, the control knob at leastpartially (typically entirely) covers the first-tube tube rotation knob,thereby preventing access to the knob by the surgeon. When in the secondposition, the control knob reveals (i.e., no longer covers) thefirst-tube tube rotation knob. The surgeon thus has convenient access tothe exposed knob.

For some application in which the implant structure comprises anannuloplasty ring, all of the tools and elements of the annuloplastysystem that are introduced into left atrium are contained within thesleeve of the annuloplasty ring, which reduces the risk that anyelements of the system will accidentally be released to the bloodcirculation, or damage surrounding tissue. In addition, the lumen of thesleeve provides guidance if it should be necessary to return to apreviously deployed anchor, such as to tighten, loosen, remove, orrelocate the anchor. For some applications, the anchors comprise helicalscrews, which facilitate such adjusting or removing.

The annuloplasty ring may be advanced toward the annulus of a valve inany suitable procedure, e.g., a transcatheter procedure, a percutaneousprocedure, a minimally invasive procedure, or an open heart procedure.

There is therefore provided, in accordance with an application of thepresent invention, apparatus including:

an implant structure, which includes a contracting mechanism, whichincludes a rotatable structure, arranged such that rotation of therotatable structure contracts the implant structure;

a longitudinal member, which is coupled to the contracting mechanism;and

a tool for rotating the rotatable structure, the tool configured to beguided along the longitudinal member, to engage the rotatable structure,and to rotate the rotatable structure in response to a rotational forceapplied to the tool.

For some applications, the longitudinal member includes at least onewire, and the tool is configured to be guided over the wire. For otherapplications, the longitudinal member includes a tube, and the tool isconfigured to be guided through the tube.

For some applications, the implant structure includes an annuloplastyring. Alternatively, the implant structure includes at least one repairchord, which is configured to pull two portions of heart tissue towardeach other upon contraction of the implant structure.

For some applications, the implant structure includes one or more tissueanchors.

For some applications, a portion of the implant structure is shaped soas to define a rack, a portion of the rotatable structure is shaped soas to define a pinion that mates with the rack, and the implantstructure is configured such that rotation of the rotatable structurecauses the portion of the implant structure to move with respect to therotatable structure.

For some applications, the implant structure includes a flexiblecontracting member that is coupled to the rotatable structure, andarranged such that rotation of the rotatable structure tightens theflexible contracting member, thereby contracting the implant structure.

For some applications, the rotatable structure includes a spool, theimplant structure is coupled to the spool, and arranged such thatrotation of the spool winds a portion of the implant structure aroundthe spool, and the tool is configured to engage and rotate the spool.For some applications, the implant structure includes a flexiblecontracting member that is coupled to the spool, the portion of theimplant structure includes a portion of the contracting member, and thecontracting member is arranged such that rotation of the spool winds theportion of the contracting member around the spool.

For some applications, the contracting mechanism includes a housing thathouses the spool, and the tool is configured to engage and rotate thespool with respect to the housing. For some applications, the toolincludes a tube, which is configured to be passed over the longitudinalmember and to engage the housing, such that the housing is heldrotationally stationary when the tube is held rotationally stationary.

For some applications, the longitudinal member is removably coupled tothe contracting mechanism. For some applications, a distal portion ofthe longitudinal member is shaped so as to define a screw thread, andthe contracting mechanism is shaped so as to define a threaded opening,into which the distal portion of the longitudinal member is screwed soas to removably coupled the longitudinal member to the contractingmechanism. For some applications, the longitudinal member is removablycoupled to the rotatable structure of the contracting mechanism. Forsome applications, the tool includes a tube, which is configured to passover the longitudinal member, and which is configured such that rotationof the tube decouples the longitudinal member from the contractingmechanism.

For some applications, the tube is a first tube, the tool furtherincludes a second tube, the first tube is positioned within the secondtube, and the second tube is configured to engage the rotatablestructure, such that rotation of the second tube rotates the rotatablestructure. For some applications, the apparatus further includes arotation handle, through which a proximal end of the longitudinal memberat least partially passes, and which includes: a first-tube rotationknob, which is coupled to the first tube, such that rotation of thefirst-tube rotation knob rotates the first tube; a second-tube rotationknob, which is coupled to the second tube, such that rotation of thesecond-tube rotation knob rotates the second tube; and a control knob,which, when in a first position, engages both first-tube and second-tuberotation knobs, and when in a second position, engages the second-tuberotation knob but not the first-tube rotation knob. For someapplications, the rotation handle includes a handle housing, and thecontrol knob, when in the second position, engages the handle housing,thereby rotationally fixing the control knob to the handle housing.

For some applications, the tool further includes a third tube, the firstand second tubes are positioned within the third tube, the rotatablestructure includes a spool, the contracting mechanism includes a housingthat houses the spool, the implant structure is coupled to the spool,and arranged such that rotation of the spool winds a portion of theimplant structure around the spool, and the second tube is configured toengage and rotate the spool with respect to the housing, and the thirdtube is configured to engage the housing, such that the housing is heldrotationally stationary when the third tube is held rotationallystationary.

For some applications, the contracting mechanism includes a lockingmechanism, the longitudinal member is shaped so as to define a distalforce applicator, which is configured to unlock the locking mechanismwhen the longitudinal member is coupled to the contracting mechanism,thereby allowing the spool to rotate with respect to the housing.

There is further provided, in accordance with an application of thepresent invention, apparatus including:

a longitudinal member;

a first tube, which passes over the longitudinal member;

a second tube, which passes over the first tube; and

a rotation handle, through which the longitudinal member at leastpartially passes, and which includes:

-   -   a first-tube rotation knob, which is coupled to the first tube,        such that rotation of the first-tube rotation knob rotates the        first tube;    -   a second-tube rotation knob, which is coupled to the second        tube, such that rotation of the second-tube rotation knob        rotates the second tube; and    -   a control knob, which:        -   when in a first position, engages both the first-tube and            second-tube rotation knobs, and        -   when in a second position, engages the second-tube rotation            knob but not the first-tube rotation knob.

For some applications, the longitudinal member includes at least onewire.

For some applications, the rotation handle is configured such that therotation of the control knob, (a) when in the first position, rotatesboth the first-tube and second-tube rotation knobs, and (b) when in thesecond position, rotates the second-tube rotation knob but not thefirst-tube rotation knob.

For some applications, the rotation handle is configured such that thecontrol knob, (a) when in the first position, at least partially coversthe first-tube rotation knob, thereby preventing access to thefirst-tube rotation knob, and (b) when in the second position, revealsthe first-tube rotation knob, thereby allowing access to the first-tuberotation knob. For some applications, the control knob is configured toslide between the first and second positions.

For some applications, the control knob is configured such that atransition between the first and second positions is not effected byrotation of the control knob.

For some applications, the control knob is configured to slide betweenthe first and second positions. For some applications, the control knobis configured such that when in the first position, an inner surface ofthe control knob engages the first-tube rotation knob and thesecond-tube rotation knob. For some applications, the rotation handleincludes a handle housing, and the sliding control knob, when in thesecond position, engages the handle housing, thereby rotationally fixingthe control knob to the handle housing. For some applications, thecontrol knob is configured that when in the second position, an outersurface of the control knob engages the handle housing.

For some applications, the apparatus further includes a third tube,which passes over the second tube, and which is coupled to the rotationhandle such that the third tube cannot rotate with respect to therotation handle.

For some applications, the first and second tubes extend from a distalend of the rotation handle, and the rotation handle includes one or moresprings which are configured to push at least one of the first andsecond tubes in a distal direction. For some applications, the rotationhandle includes a spring locking mechanism, which is configured toassume locking and released states, and, when in the locking state, toprevent at least one of the springs from pushing on at least one of thefirst and second tubes in the distal direction.

For some applications, the longitudinal member is longitudinally fixedto the rotation handle, but is allowed to rotate with respect to therotation handle. For some applications, the first and second tubesextend from a distal end of the rotation handle, and the rotation handleincludes a lever that is configured to allow the longitudinal member tobe advanced toward a proximal end of the rotation handle, whilepreventing withdrawal of the longitudinal member toward the distal endof the rotation handle.

For some applications, the apparatus further includes an implantstructure, which includes a contracting mechanism, which includes arotatable structure, arranged such that rotation of the rotatablestructure contracts the implant structure, the longitudinal member isremovably coupled to the contracting mechanism, the first tube isconfigured such that rotation of the tube decouples the longitudinalmember from the contracting mechanism, and the second tube is configuredto engage the rotatable structure, such that rotation of the second tuberotates the rotatable structure.

There is still further provided, in accordance with an application ofthe present invention, apparatus including:

a sleeve having a lumen;

a deployment manipulator tube, which is configured to be removablypositioned partially within the lumen of the sleeve, such that thedeployment manipulator tube extends out of a proximal end of the sleeve;and

a pusher tube, which is configured to pass over a portion of thedeployment manipulator tube, such that a distal end of the pusher tubeis in contact with the proximal end of the sleeve.

For some applications, the apparatus further includes an annuloplastyring, which includes the sleeve. For some applications, the annuloplastyring further includes at least one tissue anchor. For some applications,the annuloplasty ring includes a partial annuloplasty ring.

For some applications, the distal end of the pusher tube is removablycoupled to the proximal end of the sleeve. For some applications, thepusher tube includes one or more coupling elements, which are configuredto removably couple the distal end of the pusher tube to the proximalend of the sleeve. For some applications, the apparatus is configuredsuch that (a) when the deployment manipulator tube is positioned withinthe lumen of the sleeve, the deployment manipulator tube causes thecoupling elements to engage the sleeve, thereby removably coupling thedistal end of the pusher tube to the proximal end of the sleeve, and (b)when the deployment manipulator tube is withdrawn from the sleeve, thecoupling elements disengage from the sleeve, thereby decoupling thedistal end of the pusher tube from the proximal end of the sleeve. Forsome applications, the coupling elements are configured to have anatural tendency to flex inwards toward a central longitudinal axis ofthe sleeve that passes through the proximal end of the sleeve, and thedeployment manipulator tube, when positioned within the lumen of thesleeve, pushes the coupling elements outwards away from the longitudinalaxis, thereby causing the coupling elements to engage the sleeve.

For some applications, the apparatus further includes an externalcontrol handle, which is coupled to a proximal portion of the deploymentmanipulator tube and to a proximal end of the pusher tube, and which isconfigured to controllably release the pusher tube in a distal directionas the sleeve is withdrawn from the deployment manipulator tube. Forsome applications, the external control handle is configured tocontrollably release the pusher tube incrementally in the distaldirection by one or more set distances.

For some applications, the annuloplasty system further includes: atleast one tissue anchor; and an anchor deployment manipulator, whichincludes: the deployment manipulator tube; and an anchor driver, whichis configured to be at least partially positioned within the deploymentmanipulator tube, and, while so positioned, to deploy the at least oneanchor through a wall of the sleeve.

There is additionally provided, in accordance with an application of thepresent invention, apparatus for use with tissue of a subject, theapparatus including:

an anchor driver, which includes a driver head, which is shaped so as todefine one or more mechanical coupling elements, and which includes aflexible ring; and

an anchor, which includes:

-   -   a coupling head, which is shaped so as to define: (a) one or        more mating elements corresponding to the mechanical coupling        elements, and configured to engage the mechanical coupling        elements such that rotation of the mechanical coupling elements        rotates the mating elements, which in turn rotate the coupling        head, and (b) an outer coupling surface, sized to be inserted        into and engage the flexible ring; and    -   a tissue coupling element, which is fixed to the coupling head,

wherein the rotation of the mechanical coupling elements causes thetissue coupling element of the anchor to screw itself into the tissue,thereby causing separation of: (a) the outer coupling surface of thecoupling head from the flexible ring, and (b) the mating elements of thecoupling head from the corresponding mechanical coupling elements.

For some applications, the driver head includes: an inner matingcomponent, which is shaped so as to define the one or more mechanicalcoupling elements; and an outer element, which at least partiallysurrounds the inner mating component and extends in a distal directionbeyond a distal end of the inner mating component, and the flexible ringis coupled to an inner surface of the outer element. For someapplications, the outer element is configured to rotate freely withrespect to the inner mating component.

For some applications, the coupling surface of the coupling head isshaped so as to define a screw thread, such that rotation of themechanical coupling elements causes the outer coupling surface tounscrew from the flexible ring.

For some applications, the mechanical coupling elements of the driverhead include protrusions, and the mating elements of the coupling headinclude slots.

For some applications, the anchor driver further includes a shaft, andthe driver head is coupled to a distal end of the shaft. For someapplications, the inner mating component is coupled to the distal end ofthe shaft such that the inner mating component is rotationally fixed tothe shaft.

For some applications, the apparatus further includes an annuloplastyring, which includes a sleeve having a lumen, and the anchor driver isconfigured to be removably positioned within the lumen of the sleeve.

For some applications, the coupling element is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft.

There is yet additionally provided, in accordance with an application ofthe present invention, a method including:

placing, into a body of a subject, an implant structure, which includesa contracting mechanism that includes a rotatable structure, such that alongitudinal member coupled to the contracting mechanism extends outsideof the body;

guiding a tool along the longitudinal member to the rotatable subject;

engaging the rotatable structure with the tool; and

contracting the implant structure by rotating the rotatable structureusing the tool.

For some applications, the longitudinal member includes at least onewire, and guiding the tool includes guiding the tool over the wire.

For some applications, the longitudinal includes at least one tube, andguiding the tool includes guiding the tool through the tube.

For some applications, placing the implant structure includes placing anannuloplasty ring into an atrium of the body in a vicinity of an annulusof an atrioventricular valve.

For some applications, placing the implant structure includes placing atleast one repair chord into a ventricle of the body such that, uponcontracting of the implant structure, the repair chord pulls twoportions of heart tissue toward each other.

For some applications, a portion of the implant structure is shaped soas to define a rack, a portion of the rotatable structure is shaped soas to define a pinion that mates with the rack, and contracting theimplant structure includes moving the portion of the implant structurewith respect to the rotatable structure by rotating the rotatablestructure using the tool.

For some applications, the implant structure includes a flexiblecontracting member that is coupled to the rotatable structure, andcontracting the implant structure includes tightening the flexiblecontracting member by rotating the rotatable structure using the tool.

For some applications, the rotatable structure includes a spool, theimplant structure is coupled to the spool, engaging includes engagingthe spool with the tool, and contracting the implant structure includeswinding a portion of the implant structure around the spool by rotatingthe spool using the tool. For some applications, the implant structureincludes a flexible contracting member that is coupled to the spool, theportion of the implant structure includes a portion of the contractingmember, and winding includes winding the portion of the contractingmember around the spool by rotating the spool using the tool.

For some applications, the contracting mechanism including a housingthat houses the spool, and winding includes winding includes rotatingthe spool with respect to the housing. For some applications, the toolincludes a tube, and guiding the tool over the longitudinal memberincludes passing the tube over the longitudinal member and engaging thehousing with the tube such that the housing is held rotationallystationary when the tube is held rotationally stationary.

For some applications, the method further includes decoupling thelongitudinal member from the contracting mechanism after rotating therotatable structure. For some applications, a distal portion of thelongitudinal member is shaped so as to define a screw thread, thecontracting mechanism is shaped so as to define a threaded opening, intowhich the distal portion of the longitudinal member is initiallyscrewed, and decoupling includes unscrewing the longitudinal member fromthe threaded opening. For some applications, the longitudinal member isremovably coupled to the rotatable structure of the contractingmechanism, and decoupling includes decoupling the longitudinal memberfrom the rotatable structure.

For some applications, the tool includes a tube, guiding the tool overthe longitudinal member includes passing the tube over the longitudinalmember, and decoupling the longitudinal member from the contractingmechanism includes rotating the tube. For some applications, the tube isa first tube, rotating the tube includes rotating the first tube, thetool further includes a second tube, the first tube is positioned withinthe second tube, engaging includes engaging the rotatable structure withthe second tube, and contracting the implant structure includes rotatingthe rotatable structure by rotating the second tube. For someapplications, the method further includes passing a proximal end of thelongitudinal member at least partially through a rotation handle, whichincludes a first-tube rotation knob coupled to the first tube, a secondtube-rotation knob coupled to the second tube, and a control knob, which(a) when in a first position, engages both the first-tube andsecond-tube rotation knobs, and (b) when in a second position, engagesthe second-tube rotation knob but not the first-tube rotation knob, andengages a housing of the handle, thereby rotationally fixing the controlknob to the handle housing, contracting the implant structure includesrotating the first and second tubes by rotating the control knob when inthe first position, and decoupling the longitudinal member from thecontracting mechanism includes moving the control knob into the secondposition, and subsequently rotating the first tube by rotating thefirst-tube rotation knob.

For some applications, the tool further includes a third tube, the firstand second tubes are positioned within the third tube, the rotatablestructure includes a spool, the contracting mechanism includes a housingthat houses the spool, the implant structure is coupled to the spool,and contracting the implant includes: rotating a portion of the implantstructure around the spool by rotating the spool with respect to thehousing by rotating the second tube; engaging the housing with the thirdtube; and holding the housing rotationally stationary by holding thethird tube rotationally stationary.

For some applications, the contracting mechanism includes a lockingmechanism, and the longitudinal member is shaped so as to define adistal force applicator, which is configured to unlock the lockingmechanism when the longitudinal member is coupled to the contractingmechanism, thereby allowing the spool to rotate with respect to thehousing.

There is also provided, in accordance with an application of the presentinvention, a method including:

passing a longitudinal member at least partially through a rotationhandle, which includes (a) a first-tube rotation knob, which is coupledto a first tube that passes over the longitudinal member, (b) asecond-tube rotation knob, which is coupled to a second tube that passesover the first tube, and (c) a control knob, which (i) when in a firstposition, engages both the first-tube and second-tube rotation knobs,and (ii) when in a second position, engages the second-tube rotationknob but not the first-tube rotation knob, and engages a housing of thehandle, thereby rotationally fixing the control knob to the handlehousing;

rotating the first and second tubes by rotating the control knob when inthe first position; and

moving the control knob into the second position, and subsequentlyrotating the first tube by rotating the first-tube rotation knob.

For some applications, the longitudinal includes at least one wire, andpassing includes passing the wire at least partially through therotation handle.

For some applications, moving the control knob into the second positiondoes not include rotating the control knob.

For some applications, moving the control knob into the second positionincludes sliding the control knob into the second position.

For some applications, passing the longitudinal member at leastpartially through the rotation handle includes longitudinally fixing thelongitudinal member to the rotation handle such that the longitudinalmember is allowed to rotate with respect to the rotation handle.

For some applications, the method further includes:

placing, into a body of a subject, an implant structure, which includesa contracting mechanism that includes a rotatable structure, arrangedsuch that rotation of the rotatable structure contracts the implantstructure, wherein the longitudinal member is removably coupled to thecontracting mechanism;

engaging the rotatable structure with the second tube such that rotationof the second tube rotates the rotatable structure; and

engaging the longitudinal member with the first tube, such that rotationof the first tube decouples the longitudinal member from the contractingmechanism.

There is further provided, in accordance with an application of thepresent invention, a method including:

removably positioning a deployment manipulator tube partially within alumen of a sleeve of an annuloplasty ring, such that the deploymentmanipulator tube extends out of a proximal end of the sleeve; and

placing a pusher tube over the deployment manipulator tube such that adistal end of the pusher tube is in contact with the proximal end of thesleeve.

For some applications, the method further includes withdrawing thesleeve from the deployment manipulator tube in a distal direction, and,while withdrawing, pushing the pusher tube against the proximal end ofthe sleeve. For some applications, withdrawing the sleeve includes,while withdrawing the sleeve, controllably releasing the pusher tube inthe distal direction, using an external control handle to which iscoupled a proximal portion of the deployment manipulator tube and aproximal end of the pusher tube. For some applications, controllablyreleasing includes controllably releasing the pusher tube incrementallyin the distal direction by one or more set distances.

For some applications, placing includes removably coupling the distalend of the pusher tube to the proximal end of the sleeve. For someapplications, removably coupling includes using one or more one or morecoupling elements of the pusher tube to removably couple the distal endof the pusher tube to the proximal end of the sleeve. For someapplications, removably coupling includes positioning the deploymentmanipulator tube within the lumen of the sleeve such that the deploymentmanipulator tube causes the coupling elements to engage the sleeve, andthe method further includes decoupling the distal end of the pusher tubefrom the proximal end of the sleeve by withdrawing the deploymentmanipulator tube from the sleeve such that the coupling elementsdisengage from the sleeve. For some applications, the coupling elementsare configured to have a natural tendency to flex inwards toward acentral longitudinal axis of the sleeve that passes through the proximalend of the sleeve, and the deployment manipulator tube, when positionedwithin the lumen of the sleeve, pushes the coupling elements outwardsaway from the longitudinal axis, thereby causing the coupling elementsto engage the sleeve.

For some applications, the method further includes deploying at leastone anchor through a wall of the sleeve using an anchor driver that isat least partially positioned within the deployment manipulator tube.

For some applications, the annuloplasty ring is a partial annuloplastyring, and removably positioning includes removably positioning thedeployment manipulator tube partially within the lumen of the partialannuloplasty ring.

There is still further provided, in accordance with an application ofthe present invention, a method including:

advancing, into a body of a subject, (a) an anchor driver, whichincludes a driver head, which is shaped so as to define one or moremechanical coupling elements, and which includes a flexible ring, and(b) an anchor, which includes (i) a coupling head, which is shaped so asto define: (A) one or more mating elements corresponding to themechanical coupling elements, and configured to engage the mechanicalcoupling elements such that rotation of the mechanical coupling elementsrotates the mating elements, which in turn rotate the coupling head, and(B) an outer coupling surface, sized to be inserted into and engage theflexible ring, and (ii) a tissue coupling element, which is fixed to thecoupling head; and

rotating the mechanical coupling elements to cause the tissue couplingelement of the anchor to screw itself into tissue of the body, therebycausing separation of: (a) the outer coupling surface of the couplinghead from the flexible ring, and (b) the mating elements of the couplinghead from the corresponding mechanical coupling elements.

For some applications, the outer element is configured to rotate freelywith respect to the inner mating component.

For some applications, the coupling surface of the coupling head isshaped so as to define a screw thread, such that rotating the mechanicalcoupling elements causes the outer coupling surface to unscrew from theflexible ring.

For some applications, the mechanical coupling elements of the driverhead include protrusions, and the mating elements of the coupling headinclude slots.

For some applications, advancing the anchor driver includes removablypositioning the anchor driver within a lumen of a sleeve of anannuloplasty ring.

For some applications, the coupling element is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft.

There is further provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator at least partially within alumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deploymentmanipulator through a wall of the sleeve such that a coupling element ofthe anchor enters cardiac tissue of the subject in a direction parallelto a central longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator.

In an embodiment, deploying includes deploying the at least one anchorfrom the distal end of the deployment manipulator through the wall ofthe sleeve into the cardiac tissue, while the distal end of thedeployment manipulator is positioned such that the central longitudinalaxis of the deployment manipulator through the distal end of thedeployment manipulator forms an angle of between 45 and 90 degrees withthe wall of the sleeve at a point at which the anchor penetrates thewall. For some applications, the point on the wall is a first point onthe wall, and the angle is a first angle, the at least one anchor is afirst anchor of a plurality of anchors that also includes a secondanchor most recently deployed before the first anchor through a secondpoint on the wall, and deploying the first anchor includes deploying thefirst anchor while the distal end of the deployment manipulator ispositioned such that the central longitudinal axis forms a second angleof between 45 and 90 degrees with a line defined by the first point andthe second point.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and positioning the deployment manipulator includes positioning thedeployment manipulator within the lumen of the partial annuloplastyring.

In an embodiment, the deployment manipulator includes steeringfunctionality, and placing the sleeve includes steering the deploymentmanipulator using the steering functionality.

For some applications, deploying the anchor includes deploying theanchor from the atrium into an upper region of a ventricular wall nearthe atrium.

For some applications, the method further includes positioning a pusherelement at least partially within the lumen of the sleeve of theannuloplasty ring; and moving the distal end of the deploymentmanipulator proximally within the sleeve by pushing the pusher elementdistally such that the pusher element engages an interior surface of thesleeve.

In an embodiment, the method further includes tightening theannuloplasty ring by winding a flexible contracting member of the ringaround a spool coupled to the ring.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator at least partially within alumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deploymentmanipulator through a wall of the sleeve into cardiac tissue of thesubject, while the distal end of the deployment manipulator ispositioned such that a central longitudinal axis of the deploymentmanipulator through the distal end of the deployment manipulator formsan angle of between 45 and 90 degrees with the wall of the sleeve at apoint at which the anchor penetrates the wall.

For some applications, deploying includes deploying the at least oneanchor while the angle is between 75 and 90 degrees.

In an embodiment, the deployment manipulator includes steeringfunctionality, and placing the sleeve includes steering the deploymentmanipulator using the steering functionality.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and positioning the anchor deployment manipulator includes positioningthe anchor deployment manipulator at least partially within the lumen ofthe partial annuloplasty ring.

For some applications, the point on the wall is a first point on thewall, and the angle is a first angle, the at least one anchor is a firstanchor of a plurality of anchors that also includes a second anchor mostrecently deployed before the first anchor through a second point on thewall, and deploying the first anchor includes deploying the first anchorwhile the distal end of the deployment manipulator is positioned suchthat the central longitudinal axis forms a second angle of between 45and 90 degrees with a line defined by the first point and the secondpoint.

For some applications, deploying the anchor includes deploying theanchor from the distal end of the deployment manipulator such that acoupling element of the anchor enters the cardiac tissue in a directionparallel to the central longitudinal axis.

For some applications, the anchor is shaped so as to define a couplinghead and a tissue coupling element, which is shaped so as to define ashape selected from the group consisting of: a helix, a spiral, and ascrew shaft, and deploying the anchor includes screwing the tissuecoupling element into the cardiac tissue.

In an embodiment, the method further includes tightening theannuloplasty ring by winding a flexible contracting member of the ringaround a spool coupled to the ring.

For some applications, deploying the anchor includes deploying theanchor from the atrium into an upper region of a ventricular wall nearthe atrium.

For some applications, the deployment manipulator includes an anchordriver positioned within a sheath, the at least one anchor includes aplurality of anchors, and deploying the at least one anchor includes:

-   -   loading a first one of the anchors onto the anchor driver;    -   deploying the first one of the anchors through a wall of the        sleeve and into the cardiac tissue;    -   withdrawing the anchor driver from the sheath and a body of the        subject, while leaving the sheath lumen of the sleeve;    -   subsequently loading a second one of the anchors onto the anchor        driver while the anchor driver is outside the body;    -   subsequently reintroducing the anchor driver into the body and        the sheath; and    -   subsequently deploying the second one of the anchors through the        wall of the sleeve into the cardiac tissue.

For some applications, placing the at least a portion of the sleeveincludes placing the at least a portion of the sleeve into a rightatrium of the subject in a vicinity of a tricuspid valve. Alternatively,placing the at least a portion of the sleeve includes placing the atleast a portion of the sleeve into a left atrium of the subject in avicinity of the annulus of a mitral valve.

There is yet additionally provided, in accordance with an embodiment ofthe present invention, a method including:

positioning, during a transcatheter procedure, an anchor deploymentmanipulator at least partially in an atrium of a subject;

placing, into the atrium in a vicinity of an annulus of anatrioventricular valve, at least a portion of an annuloplasty ring; and

coupling the annuloplasty ring to cardiac tissue by deploying at leastone anchor from the deployment manipulator in the atrium and into anupper region of a ventricular wall near the atrium.

Typically, the atrioventricular valve is selected from the groupconsisting of: a mitral valve and a tricuspid valve.

In an embodiment, positioning the anchor deployment manipulator includespositioning at least a distal end of the deployment manipulator within alumen of a sleeve of the annuloplasty ring, and coupling includescoupling the ring to the cardiac tissue by deploying the at least oneanchor from the distal end of the deployment manipulator in the atrium,through a wall of the sleeve, and into the upper region of theventricular wall. For some applications, deploying the anchor includesdeploying the anchor into the upper region of the ventricular wall whilethe distal end of the deployment manipulator is positioned such that acentral longitudinal axis of the deployment manipulator through thedistal end of the deployment manipulator forms an angle of between 45and 90 degrees with the wall of the sleeve at a point at which theanchor penetrates the wall.

For some applications, deploying the anchor includes deploying theanchor from the distal end of the deployment manipulator into the upperregion of ventricular wall such that a coupling element of the anchorenters the ventricular wall in a direction parallel to a centrallongitudinal axis of the deployment manipulator through the distal endof the deployment manipulator.

There is further provided, in accordance with an embodiment of thepresent invention, a method including:

positioning an anchor deployment manipulator and a pusher element atleast partially within a lumen of a sleeve of an annuloplasty ring;

placing, into an atrium of a subject in a vicinity of an annulus of anatrioventricular valve, at least a portion of the sleeve that contains adistal end of the deployment manipulator and a distal end of the pusherelement;

moving the distal end of the deployment manipulator proximally withinthe sleeve by pushing the pusher element distally such that the pusherelement engages an interior surface of the sleeve; and

after moving the distal end of the deployment manipulator, deploying ananchor from the distal end of the deployment manipulator through a wallof the sleeve into cardiac tissue.

For some applications, the deployment manipulator includes an outer tubethat is shaped so as to define an opening that is within 3 mm of adistal end of the tube, and positioning the pusher element at leastpartially within the lumen of the sleeve includes positioning the pusherelement such that (a) a distal portion of the pusher element extends outof the tube through the opening and into the lumen of the sleeve, and(b) a proximal portion of the pusher element passes through the tubefrom the opening to a proximal end of the tube.

For some applications, the deployment manipulator includes an outertube, and positioning the pusher element at least partially within thelumen of the sleeve includes positioning the pusher element outside ofthe outer tube.

For some applications, moving includes moving the distal end of thedeployment manipulator by pushing the pusher element distally such thatthe pusher element engages a distal end of the sleeve. Alternatively oradditionally, moving includes moving the distal end of the deploymentmanipulator by pushing the pusher element distally such that the pusherelement engages the wall of the sleeve.

For some applications, moving the distal end of the deploymentmanipulator includes moving the distal end of the deployment manipulatora certain distance by pushing the pusher element the certain distance.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including:

coupling a sleeve of an annuloplasty ring to cardiac tissue of a subjectat a plurality of sites in a vicinity of an annulus of anatrioventricular valve;

partially inserting a screwdriver tool into a lumen of the sleeve, thetool having a head and a shaft; and

rotating the screwdriver tool such that the head, while within the lumenof the sleeve, shortens the ring by rotating a contracting mechanism ofthe ring that tightens an elongated contracting member coupled to thesleeve.

Typically, the annuloplasty ring includes a partial annuloplasty ring,and coupling includes coupling the sleeve of the partial annuloplastyring to the cardiac tissue.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are schematic illustrations of an adjustable partialannuloplasty ring in a non-contracted state, in accordance withrespective applications of the present invention;

FIG. 2 is a schematic longitudinal cross-sectional illustration of ananchor deployment manipulator, in accordance with an application of thepresent invention;

FIG. 3 is a schematic longitudinal cross-sectional illustration of theanchor deployment manipulator of FIG. 2 advanced into the annuloplastyring of FIG. 1A, in accordance with an application of the presentinvention;

FIG. 4 is a schematic cross-sectional illustration of the anchordeployment manipulator of FIG. 2 advanced into the annuloplasty ring ofFIGS. 1A or 1B, taken along section IV-IV of FIG. 3 , in accordance withan application of the present invention;

FIGS. 5A-B are schematic illustrations of a rotation tool being used torotate a spool of a contracting mechanism of the rings of FIGS. 1A and1B, respectively, in accordance with respective applications of thepresent invention;

FIGS. 6A and 6B are schematic isometric and cross-sectionalillustrations, respectively, of another configuration of a rotation toolbeing used to rotate a spool of a contracting mechanism of the ring ofFIG. 1B, in accordance with an application of the present invention;

FIG. 7 shows a relationship among individual components of thecontracting mechanism of FIGS. 6A and 6B, in accordance with anapplication of the present invention;

FIG. 8 is another cross-sectional illustration of the contractingmechanism of FIGS. 6A and 6B, in accordance with an application of thepresent invention;

FIGS. 9A-C are schematic cross-sectional illustrations of a rotationhandle, in accordance with an application of the present invention;

FIGS. 10A-D are schematic isometric illustrations of the rotation handleof FIGS. 9A-C, in accordance with an application of the presentinvention;

FIGS. 11A-I are schematic illustrations of a procedure for implantingthe annuloplasty ring of FIG. 1A to repair a mitral valve, in accordancewith an application of the present invention;

FIG. 12 is a schematic illustration of the deployment of an anchor intocardiac tissue, in accordance with an application of the presentinvention;

FIG. 13 is a schematic illustration of the system of FIGS. 1-4comprising a flexible pusher element, in accordance with an applicationof the present invention;

FIG. 14 is a schematic illustration of a pusher tube applied to aproximal end of the sleeve of FIGS. 1-4 , in accordance with anapplication of the present invention;

FIGS. 15 and 16 are schematic illustrations of the system of FIGS. 1-4comprising a steerable tube, in accordance with respective applicationsof the present invention;

FIG. 17 is a schematic illustration of the system of FIGS. 1-4comprising a pulling wire, in accordance with an application of thepresent invention;

FIGS. 18A and 18B are schematic illustrations of another configurationof the pusher tube of FIG. 14 , in accordance with an application of thepresent invention;

FIG. 19 is a schematic illustration of the system of FIGS. 1-4 and FIGS.18A-B comprising an external control handle, in accordance with anapplication of the present invention;

FIGS. 20A-E are schematic cross-sectional and isometric illustrations ofa configuration of a driver head of an anchor driver, in accordance withan application of the present invention;

FIG. 21 is a schematic illustration of an implant structure comprisingrepair chords, in accordance with an application of the presentinvention;

FIGS. 22A and 22B are schematic illustrations of another implantstructure comprising repair chords, in accordance with respectiveapplications of the present invention;

FIG. 23 is a schematic illustration of another configuration of acontracting mechanism and an implant structure, in accordance with anapplication of the present invention; and

FIGS. 24A-B and 25 are schematic illustrations of a valve prosthesisassembly, in accordance with an application of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1-4 are schematic illustrations of a system 20 for repairing adilated atrioventricular valve, such as a mitral valve, in accordancewith an application of the present invention. System 20 comprises anadjustable partial annuloplasty ring 22, shown alone in FIGS. 1A and 1Bin a non-contracted state, and an anchor deployment manipulator 24,shown alone in FIG. 2 . Annuloplasty ring 22 comprises a flexible sleeve26. Anchor deployment manipulator 24 is advanced into sleeve 26, asshown in FIGS. 3 and 4 , and, from within the sleeve, deploys anchors 38through a wall of the sleeve into cardiac tissue, thereby anchoring thering around a portion of the valve annulus.

FIGS. 1A and 1B are schematic illustration of annuloplasty ring 22 in anon-contracted state, in accordance with respective applications of thepresent invention. Sleeve 26 is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus.

Alternatively, the ring is configured to be placed entirely around thevalve annulus. In order to tighten the annulus, annuloplasty ring 22comprises a flexible elongated contracting member 30 that extends alongthe ring.

Annuloplasty ring 22 further comprises a contracting mechanism 40, whichfacilitates contracting of the annuloplasty ring. Contracting mechanism40 is described in more detail hereinbelow. In addition, the ringcomprises a plurality of anchors 38, typically between about 5 and about20 anchors, such as about 10 or about 16 anchors. In FIGS. 1A and 1B,anchors 38 are shown prior to their insertion into ring 22, while inFIG. 3 one of the anchors is shown deployed through the wall of sleeve26, and a second one of the anchors is shown during deployment by anchordeployment manipulator 24. The insertion of the anchors into the sleeveand deployment of the anchors into cardiac tissue is described in detailhereinbelow.

Flexible sleeve 26 may comprise a braided, knitted, or woven mesh or atubular structure comprising ePTFE. For some applications, the braidcomprises metal and fabric fibers. The metal fibers, which may compriseNitinol for example, may help define the shape of the sleeve, e.g., holdthe sleeve open to provide space for passage and manipulation ofdeployment manipulator 24 within the sleeve. The fabric fibers maypromote tissue growth into the braid. Optionally, the sleeve is somewhatelastic, which gives the sleeve a tendency to longitudinally contract,thereby helping tighten the sleeve. For example, the sleeve may bebellows- or accordion-shaped.

Typically, the sleeve is configured to have a tendency to assume astraight shape. This straightness helps the surgeon locate the next sitefor each subsequent anchor during the implantation procedure, asdescribed hereinbelow with reference to FIGS. 11A-I. For example,because the sleeve assumes a generally straight shape, the sleeve mayhelp provide an indication of distance between adjacent anchoring sites.

For some applications, the sleeve is configured to have a controllablyvariable stiffness.

For example, a somewhat stiff wire may be placed in the sleeve toprovide the stiffness, and subsequently be removed at the conclusion ofthe implantation procedure when the stiffness is no longer useful.

Elongated contracting member 30 comprises a wire, a ribbon, a rope, or aband, which typically comprises a flexible and/or superelastic material,e.g., nitinol, polyester, stainless steel, or cobalt chrome. For someapplications, the wire comprises a radiopaque material. For someapplications, contracting member 30 comprises a braided polyester suture(e.g., Ticron). For some applications, contracting member 30 is coatedwith polytetrafluoroethylene (PTFE). For some applications, contractingmember 30 comprises a plurality of wires that are intertwined to form arope structure.

For some applications, contracting member 30 is positioned at leastpartially within a lumen of the sleeve 26, such as entirely within thelumen (as shown in FIGS. 1A-B, 5A-B, 6A, 11H, and 11I). For someapplications in which the contracting member is positioned partiallywithin the lumen, the contracting member is sewn into the wall of thesleeve, such that the contracting member is alternatingly inside andoutside of the sleeve along the length of the sleeve (as shown in FIGS.3 , 13, and 14). Optionally, sleeve 26 defines an internal channelwithin which member 30 is positioned (configuration not shown).Alternatively, the contracting member is disposed outside the lumen ofthe sleeve, such as alongside an outer wall of the sleeve. For example,sleeve 26 may define an external channel within which member 30 ispositioned, or the sleeve may comprise or be shaped so as to defineexternal coupling elements, such as loops or rings (configuration notshown). For some applications, contracting member 30 is positionedapproximately opposite the anchors.

For some applications of the present invention, contracting mechanism 40comprises a rotatable structure, such as a spool 46. The rotatablestructure is arranged such that rotation thereof contracts annuloplastyring 22. For some applications, a first end 47 of contracting member 30is coupled to the spool. For some applications, contracting mechanism 40further comprises a housing 44 that houses the rotatable structure,e.g., the spool. Spool 46 is positioned in a vicinity of (e.g., within 1cm of) either a distal end 51 of sleeve 26, as shown in FIGS. 1A and 3 ,or a proximal end 49 of sleeve 26, as shown in FIG. 1B. For someapplications, a second end 53 of contracting member 30 is coupled to thesleeve in a vicinity of (e.g., within 1 cm of) the end of the sleeveopposite the end to which the spool is positioned. In the configurationshown in FIGS. 1A and 3 , second end 53 of contracting member 30 iscoupled to the sleeve in a vicinity of proximal end 49 of the sleeve,while in the configuration shown in FIG. 1B, the second end of thecontracting member is coupled to the sleeve in a vicinity of distal end51 of the sleeve. Rotation of spool 46 winds a portion of thecontracting member around the spool, thereby pulling the far end of thering toward the spool and shortening and tightening the ring.

Alternatively, in some configurations, spool 46 is positioned at anintermediary position along the sleeve, rather than in a vicinity of oneof the ends. For these configurations, contracting member 30 comprisestwo contracting members, which are respectively connected to the twoends of the sleeve, and both of which are connected to the spool.Rotating the spool contracts both contracting members. Theseconfiguration may be implemented using techniques described in U.S.patent application Ser. No. 12/341,960 to Cabiri, which published as USPatent Application Publication 2010/0161047 and is incorporated hereinby reference, with reference to FIG. 15 thereof.

For some applications, spool 46 is shaped to provide a hole 42 or othercoupling mechanism for coupling first end 47 of contracting member 30 tothe spool, and thereby to contracting mechanism 40.

For other applications, contracting member 30 comprises at least onewire (e.g., exactly one wire) that passes through a coupling mechanismof spool 46, in order to couple the wire to the spool. The ends of thewire are brought together, and together serve as second end 53 ofcontracting member 30, and may be coupled to one of the severallocations of the sleeve mentioned hereinabove. In this configuration,approximately the longitudinal center of the wire serves as first end 47of the contracting member.

For some applications, spool 46 is shaped to define a driving interface48. For some applications, driving interface 48 is female. For example,the interface may be shaped to define a channel which extends throughthe cylindrical portion of spool 46 from an opening provided by an uppersurface 50 of spool 46 to an opening provided by a lower surface 52 ofspool 46. Alternatively, driving interface 48 is shaped so as to definean indentation (e.g., a groove) that does not extend entirely throughthe cylindrical portion of the spool. Further alternatively, drivinginterface 48 is male, and defines a protrusion, e.g., a hexagonal heador a head having another shape.

For some applications, a distal portion of a rotation tool 80, which isdescribed hereinbelow with reference to FIGS. 5A-B, engages spool 46 viadriving interface 48 and rotates spool 46 in response to a rotationalforce applied to the rotation tool. The rotational force applied to therotation tool rotates spool 46 via the portion of the rotation tool thatengages driving interface 48 of spool 46.

Spool 46 typically comprises a locking mechanism that prevents rotationof the spool after contracting member 30 has been tightened. Forexample, locking techniques may be used that are described withreference to FIG. 4 of above-mentioned U.S. application Ser. No.12/341,960 to Cabiri, and/or with reference to FIGS. 6B, 7, and 8hereinbelow.

Alternatively, for some applications, contracting mechanism 40 isconfigured to tighten contracting member 30, crimp the contractingmember to hold the contracting member taut, and subsequently cut theexcess length of the contracting member.

FIG. 2 is a schematic longitudinal cross-sectional illustration ofanchor deployment manipulator 24, FIG. 3 is a schematic longitudinalcross-sectional illustration of the anchor deployment manipulatoradvanced into annuloplasty ring 22, and FIG. 4 is a schematiccross-sectional illustration of the anchor deployment manipulatoradvanced into the annuloplasty ring, taken along section IV-IV of FIG. 3, in accordance with an application of the present invention.

Anchor deployment manipulator 24 is advanced into a lumen of sleeve 26,and, from within the lumen, deploys anchors 38 through a wall of thesleeve and into cardiac tissue, thereby anchoring the sleeve around aportion of the valve annulus. Typically, annuloplasty ring 22 and anchordeployment manipulator 24 are introduced into the heart via a sheath104, as described hereinbelow with reference to FIGS. 11A-I.

For some applications, at least one of anchors 38 is deployed from adistal end 60 of deployment manipulator 24 while the distal end ispositioned such that a central longitudinal axis 62 through distal end60 of deployment manipulator 24 forms an angle α (alpha) of betweenabout 45 and 90 degrees with the wall of sleeve 26 at the point at whichthe anchor penetrates the wall, such as between about 75 and 90 degrees,e.g., about 90 degrees. (In FIG. 3 , a line 64 schematically illustratesthe plane tangential to the wall of the sleeve at the anchor-penetrationpoint.) This anchor-penetration point is typically at a portion of thesleeve that extends distally beyond the distal end of outer tube 66 ofdeployment manipulator 24 (which is described hereinbelow), i.e., thatis no longer in contact with the outer surface of outer tube 66.Typically, all of the anchors are deployed at such angles, with thepossible exception of the first anchor deployed near the distal end ofthe sleeve.

For some applications, at least one of anchors 38 is deployed fromdistal end 60 of deployment manipulator 24 while distal end 60 ispositioned such that longitudinal axis 62 through distal end 60 ofdeployment manipulator 24 forms an angle β (beta) of between about 45and 90 degrees (such as between about 75 and 90 degrees, e.g., about 90degrees) with a line 65 defined by (a) a first point 67 at which theanchor currently being deployed penetrates the wall of the sleeve and(b) a second point 69 at which a most recently previously deployedanchor penetrates the wall of sleeve 26. Typically, all of the anchorsare deployed at such angles, with the exception of the first anchordeployed near the distal end of the sleeve.

Typically, the anchors are deployed from distal end 60 of deploymentmanipulator 24 into the cardiac tissue in a direction parallel tocentral longitudinal axis 62.

For some applications, anchor deployment manipulator 24 comprises anouter tube 66 (sometimes referred to herein, including in the claims, asa “deployment manipulator tube”) and an anchor driver 68 which is atleast partially positioned within tube 66. Anchor driver 68 comprises anelongated, flexible shaft 70, having at its distal end a driver head 72.Rotation of the anchor driver screws the anchors into the cardiactissue. Each of anchors 38 is shaped so as to define a coupling head 74and a tissue coupling element 76. The anchors are typically rigid.Tissue coupling elements 76 may, for example, be helical or spiral inshape (e.g., having the shape of a corkscrew), as shown in the figures,may comprise screws, or may have other shapes. Coupling heads 74 may beeither male (e.g., a hex or square protrusion) or female (e.g., astraight slot, a hex opening, a Phillips opening, or a Robertsonopening). The use of helical anchors, which are screwed into the cardiactissue, generally minimizes the force that needs to be applied duringdeployment of the anchors into the cardiac tissue. Alternatively, theanchors may comprise staples, clips, spring-loaded anchors, or othertissue anchors described in the references incorporated hereinabove inthe Background section, or otherwise known in the art. For someapplications, anchor deployment manipulator 24 and/or anchors 38 areimplemented using techniques described hereinbelow with reference toFIGS. 20A-E.

For some applications, outer tube 66 of deployment manipulator 24 issteerable, as known in the catheter art, while for other applications, aseparate steerable tube is provided, as described hereinbelow withreference to FIG. 15 or FIG. 16 . To provide steering functionality todeployment manipulator 24, outer tube 66, steerable tube 300 (FIG. 15 ),or steerable tube 320 (FIG. 16 ), as the case may be, typicallycomprises one or more steering wires, the pulling and releasing of whichcause deflection of the distal tip of the tube.

For some applications of the present invention, each of tissue couplingelements 76 is shaped so as to define a longitudinal axis 78 (shown inFIGS. 1A-B), and is configured to penetrate the cardiac tissue in adirection parallel to longitudinal axis 78. Deployment manipulator 24 isconfigured to deploy tissue coupling element 76 from distal end 60 ofthe deployment manipulator through the wall of sleeve 26 in a directionparallel to longitudinal axis 78 and parallel to central longitudinalaxis 62 through distal end 60 of deployment manipulator 24 (shown inFIGS. 2, 3, and 12-15 ).

For some applications, the plurality of anchors are applied using thedeployment manipulator by loading a first one of the anchors onto theanchor driver, and deploying the anchor into the cardiac tissue. Theanchor driver is withdrawn from the subject's body (typically whileleaving outer tube 66 of the deployment manipulator in place in thesleeve), and a second one of the anchors is loaded onto the anchordriver. The anchor driver is reintroduced into the outer tube of thedeployment manipulator, and the second anchor is deployed. These stepsare repeated until all of the anchors have been deployed. Alternatively,the entire deployment manipulator, including the anchor driver, isremoved from the body and subsequently reintroduced after being providedwith another anchor. Further alternatively, the deployment manipulatoris configured to simultaneously hold a plurality of anchors, and todeploy them one at a time (configuration not shown).

Typically, the first anchor 38 is deployed most distally in sleeve 26(generally at or within a few millimeters of a distal end 51 of thesleeve), and each subsequent anchor is deployed more proximally, suchthat sleeve 26 is gradually pulled off (i.e., withdrawn from) deploymentmanipulator 24 in a distal direction during the anchoring procedure.Typically, as the sleeve is pulled off the deployment manipulator, thedeployment manipulator is moved generally laterally along the cardiactissue, as shown in FIG. 3 .

For some applications, an implant structure is provided. The implantstructure comprises a contracting mechanism, such as contractingmechanism 40. The contracting mechanism comprises a rotatable structure,arranged such that rotation of the rotatable structure contracts theimplant structure. The implant further comprises a longitudinal member,which is coupled to the contracting mechanism. A tool, such as rotationtool 80, is provided for rotating the rotatable structure. The tool isconfigured to be guided over the longitudinal member, to engage therotatable structure, and to rotate the rotatable structure in responseto a rotational force applied to the tool.

Reference is now made to FIGS. 5A-B, which are schematic illustrationsof rotation tool 80 being used to rotate spool 46 of contractingmechanism 40 of ring 22, in accordance with respective applications ofthe present invention. For these application, the implant structurecomprises annuloplasty ring 22. Rotation tool 80 has a head 82 that iseither male (e.g., comprising a screwdriver head, having, such as aslot-head, an Allen-head, a Phillips-head, a Robertson-head, or ahex-head) or female (e.g., comprising a wrench head, having, forexample, a square or hex opening), as appropriate for the drivinginterface provided. Typically, the rotation tool comprises a shaft 84,at least a portion of which is flexible. For some applications, therotation tool is used that is described in above-referenced U.S. patentapplication Ser. No. 12/341,960, with reference to FIG. 4 thereof.Alternatively, anchor driver 68 of deployment manipulator 24 serves asrotation tool 80, and is used to rotate the spool, in which case drivinginterface 48 is appropriately shaped to receive driver head 72 of anchordriver 68.

In the configuration shown in FIG. 5A, contracting member 30 is coupledto distal end 51 of sleeve 26, as shown hereinabove in FIGS. 1A and 3 .Contracting mechanism 40 is oriented such that driving interface 48thereof is accessible from within sleeve 26. Rotation tool 80 isinserted into sleeve 26, and used to rotate spool 46 via the drivinginterface. Alternatively, anchor driver 68 of deployment manipulator 24serves as rotation tool 80, and is used to rotate the spool, in whichcase driving interface 48 is appropriately shaped to engage driver head72 of anchor driver 68. In either case, the sleeve thus serves to guidethe rotation tool to driving interface 48. For some applications, aninterior surface of the sleeve is tapered near the distal end of thesleeve, to help guide the head 82 of rotation tool 80 to the drivinginterface. For some applications, during the implantation procedure,anchor deployment manipulator 24 is left slightly inserted into proximalend 49 of sleeve 26 after all of anchors 38 have been deployed, in orderto facilitate passage of rotation tool 80 into sleeve 26.

In the configuration shown in FIG. 5B, access to driving interface 48 isprovided from outside sleeve 26. For some applications, contractingmechanism 40 comprises a longitudinal member 86, such as a wire, that isattached to the mechanism and passes out of the body of the subject,typically via sheath 104. In order to readily bring the rotation tool todriving interface 48, rotation tool 80 is guided over (as shown) thelongitudinal member, or alongside the longitudinal member (configurationnot shown). Alternatively, the longitudinal member comprises a suture orother highly flexible element. For some applications, the longitudinalmember comprises a tube, through which rotation tool 80 is passed tobring the tool to the driving interface 48. For some applications,longitudinal member 86 has a diameter of between 0.1 and 1 mm, such as0.4 mm.

For some applications, longitudinal member 86 is looped throughcontracting mechanism 40, and both ends of the longitudinal member arebrought together and extend outside of the subject's body. Thelongitudinal member is decoupled from the contracting mechanism byreleasing one end of the longitudinal member, and pulling on the otherend to draw the longitudinal member away from the contracting mechanism.

For some applications, contracting mechanism 40 is positioned in avicinity of (e.g., within 1 cm of) distal end 51 of sleeve 26, andaccess to driving interface 48 is provided from outside sleeve 26, asdescribed with reference to FIG. 5B (in which the contracting mechanismis positioned in a vicinity of proximal end 49 of the sleeve).

For some applications in which access to driving interface 48 isprovided from outside sleeve 26, the rotation tool is initiallyremovably attached to the driving interface, prior to the commencementof the implantation procedure, and is subsequently decoupled from thedriving interface after spool 46 has been rotated. In theseapplications, contracting mechanism 40 may be positioned in a vicinityof distal end 51 or proximal end 49 of sleeve 26, or at an intermediatelocation along the sleeve. Optionally, at least a portion of a shaft ofthe rotation tool is positioned within sheath 104, which is describedhereinbelow with reference to FIGS. 11A-I.

Reference is now made to FIGS. 6A and 6B, which are schematic isometricand cross-sectional illustrations, respectively, of anotherconfiguration of rotation tool 80 being used to rotate spool 46 ofcontracting mechanism 40 of ring 22, in accordance with an applicationof the present invention. In this application, as in the configurationsshown in FIGS. 1B and 5B, access to driving interface 48 is providedfrom outside sleeve 26. Contracting mechanism 40 comprises longitudinalmember 86 that is attached to the contracting mechanism 40 and passesout of the body of the subject, typically via sheath 104. In order toreadily bring the rotation tool to driving interface 48, rotation tool80 is guided over longitudinal member 86. In this application, rotationtool 80 comprises one or more tubes that pass over the longitudinalmember, as described below.

As mentioned above, for some application longitudinal member comprises awire, which may comprise metal. Because the wire is fairly stiff, thewire generally maintains its direction and orientation with respect tocontracting mechanism 40. The wire thus readily guides the tubes to thecontracting mechanism such that the tubes have a desired orientation andposition with respect to the contracting mechanism.

Longitudinal member 86 is removably coupled to contracting mechanism 40,typically to a central portion of upper surface 50 of spool 46. For someapplications, a distal portion 88 of longitudinal member 86 is shaped soas to define a screw thread 90. Distal portion 88 is screwed into athreaded opening 92 of upper surface 50, in order to removably couplelongitudinal member 86 to contracting mechanism 40. Typically, thedistal portion is initially coupled to the contracting mechanism beforeannuloplasty ring 22 is placed into an atrium of the patient. Asdescribed below, the distal portion is decoupled from the contractingmechanism after spool 46 has been rotated to tighten ring 22. For someapplications, distal portion 88 comprises a discrete element that isfixed to longitudinal member 86, while for other application, distalportion 88 is integral with longitudinal member 86.

For some applications, rotation tool 80 comprises an inner (first) tube98, an intermediate (second) tube 96, and, optionally, an outer (third)tube 94. Rotation of each of the tubes is independently controlled, suchas using techniques described hereinbelow with reference to FIGS. 9A-Cand/or 10A-D.For some applications, a distal portion of each of tubes94, 96, and 98 that enters the patient's body comprises braided plastic,and a proximal portion of each of the tubes that does not enter thepatient's body comprises a hard material, such as metal (not shown). Forexample, the distal and proximal portions may have lengths of between 50and 100 cm and between 50 and 350 cm, respectively. Distal-most portions94D, 96D, and 98D, respectively, of the distal portions typicallycomprise a hard material, such as metal, in order to engage otherelements, as described immediately below. Typically, the distal-mostportions comprise separate elements that are coupled to their respectivetubes. For example, the distal-most portions may have lengths of between1 and 10 mm.

Intermediate tube 96 is configured to rotate spool 46. To this end,intermediate tube 96 (such as distal-most portion 96D thereof) isconfigured to engage upper surface 50 of spool 46. To enable suchengagement, the upper surface typically is shaped so as to define one ormore indentations 99 (e.g., grooves), in which corresponding protrusionsat the distal end of intermediate tube 96 are positioned, such as bygently rotating tube 96 (or all of the tubes) until such engagementoccurs. (Springs 460, described hereinbelow with reference to FIGS. 9A-Cand 10A-D, may be provided to assist with such engagement.) The radiusof intermediate tube 96 is approximately equal to the distance of eachof the indentations from a center of upper surface 50, so that theprotrusions at the distal end of the tube are aligned with theindentations. Alternatively, the upper surface defines one or moreprotrusions, which engage indentations on the distal end of tube 96(configuration not shown). Indentations 99 or the protrusions thus serveas driving interface 48.

Rotation of intermediate tube 96 causes corresponding rotation of spool46, thereby winding contracting member 30 around the spool, andtightening the contracting member.

Outer tube 94, if provided, is configured to prevent rotation of spoolhousing 44 during rotation of spool 46. To this end, outer tube 94 (suchas distal-most portion 94D thereof) is configured to engage an uppersurface 160 of spool housing 44. To enable such engagement, the uppersurface typically is shaped so as to define one or more indentations 162(e.g., grooves), in which corresponding protrusions at the distal end ofouter tube 94 are positioned, such as by gently rotating the tube (orall of the tubes) until such engagement occurs. (Springs 460, describedhereinbelow with reference to FIGS. 9A-C and 10A-D, may be provided toassist with such engagement.) The radius of outer tube 94 isapproximately equal to the distance of each of the indentations from acenter of spool housing 44, so that the protrusions at the distal end ofthe tube are aligned with the indentations. Alternatively, the uppersurface defines one or more protrusions, which engage indentations onthe distal end of tube 94 (configuration not shown).

During rotation of intermediate tube 96 for rotating spool 46, outertube 94 is held rotationally stationary, thereby stabilizing spoolhousing 44 and enabling spool 46 to rotate with respect to housing 44.

Inner tube 98 is configured to decouple longitudinal member 86 fromspool 46 after contracting member 30 has been sufficiently wound aroundthe spool, as described above. To this end, a distal portion of theinner tube (such as distal-most portion 98D thereof) is shaped so as toengage a distal portion of longitudinal member 86, which is typicallyshaped so as to couple with the distal portion of the inner tube.

Rotation of the inner tube, while intermediate tube 96 is prevented fromrotating and thus prevents rotation of spool 46, causes correspondingrotation of longitudinal member 86, and unscrews the longitudinal memberfrom spool 46. Longitudinal member 86 and spool 46 are typicallyconfigured such that this unscrewing rotation is in the oppositedirection of the rotation of the spool that tightens the contractingmember. For example, clockwise rotation of the spool (looking down onthe spool) may wind the contracting member around the spool, whilecounterclockwise rotation of longitudinal member 86 unscrews thelongitudinal member from the spool. To enable the engagement of innertube 98 with the distal portion of the longitudinal member, the distalportion may include a flat portion.

FIG. 7 shows a relationship among individual components of contractingmechanism 40, in accordance with an application of the presentinvention. Contracting mechanism 40 is shown as comprising spool housing44 which defines an upper surface 160 and a recessed portion 176. Spool46 is configured to be disposed within housing 44 and defines an uppersurface 178, a lower surface 180 and a cylindrical body portion disposedvertically between surfaces 178 and 180.

Lower surface 180 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) recesses 182 which define structural barrierportions 188 of lower surface 180. It is to be noted that any suitablenumber of recesses 182 may be provided, e.g., between 1 and 10 recesses,circumferentially with respect to lower surface 180 of spool 46.

For some applications, as mentioned above, spool 46 comprises a lockingmechanism 164. For some applications, locking mechanism 164 is coupled,e.g., welded, at least in part to a lower surface of spool housing 44.Typically, locking mechanism 164 defines a mechanical element having aplanar surface that defines slits 184. The surface of locking mechanism164 may also be curved, and not planar. Locking mechanism 164 is shapedto provide a protrusion 166 which projects out of a plane defined by theplanar surface of the mechanical element. The slits define a depressibleportion 168 of locking mechanism 164 that is disposed in communicationwith and extends toward protrusion 166. Depressible portion 168 ismoveable in response to a force applied thereto by a distal element 70that extends in a distal direction from distal portion 88 oflongitudinal member 86, beyond threaded opening 92 of upper surface 50,as shown in FIG. 6B.

It is to be noted that the planar, mechanical element of lockingmechanism 164 is shown by way of illustration and not limitation andthat any suitable mechanical element having or lacking a planar surfacebut shaped to define at least one protrusion may be used together withlocking mechanism 164.

A cap 170 is provided that is shaped so as to define a planar surfaceand an annular wall having an upper surface 186 that is coupled to,e.g., welded to, a lower surface of spool housing 44. The annular wallof cap 170 is shaped so as to define a recessed portion 172 of cap 170that is in alignment with recessed portion 176 of spool housing 44.

Reference is again made to FIG. 6B, and is additionally made to FIG. 8 ,which is another cross-sectional illustration of contracting mechanism40, in accordance with an application of the present invention. FIG. 6Bshows contracting mechanism 40 in an unlocked state, while FIG. 8 showsthe contracting mechanism in a locked state.

In the unlocked state shown in FIG. 6B, protrusion 166 of lockingmechanism 164 is disposed within recessed portion 172 of cap 170.Longitudinal member 86 is shaped so as to define a distal forceapplicator 174 that extends distally, typically beyond screw thread 90.In the unlocked state, the force applicator extends through spool 46 andpushes against depressible portion 168 of locking mechanism 164. Thedepressible portion is thus pressed downward, as shown in FIG. 6B,freeing protrusion 166 from within a recess 190 defined by structuralbarrier portions 188 of the lower portion of spool 46. Additionally,protrusion 166 is freed from within recessed portion 176 provided byspool housing 44. As a result, contracting mechanism 40 is unlocked, andspool 46 may be rotated with respect to spool housing 44.

Cap 170 functions to restrict distal pushing of depressible portion 168beyond a desired distance so as to inhibit deformation of lockingmechanism 164. For applications in which contracting mechanism 40 isimplanted in heart tissue, cap 170 also provides an interface betweencontracting mechanism 40 and the heart tissue. This preventsinterference of heart tissue on contracting mechanism 40 during thelocking and unlocking thereof. Additionally, cap 170 prevents damage toheart tissue by depressible portion 168 as it is pushed downward.

In the locked state shown in FIG. 8 , protrusion 166 is positionedwithin a recess 190 of spool 46. Typically, the locked state is theresting state of locking mechanism 162. Depressible portion 168 isdisposed in a horizontal position, in response to removal of distalforce applicator 174 from within spool 46. Depressible portion 168 has atendency to assume the horizontal position, as shown, and in the absenceof a downward pushing force applied to depressible portion 168 by forceapplicator 174, depressible portion 168 returns to its horizontalposition from its pushed-down state, as shown in FIG. 8 . In thishorizontal position, protrusion 166 of locking mechanism 164 is removedfrom recessed portion 172 of cap 170 and is returned within a recess 190of spool 46 and thereby restricts movement of spool 46 and lockscontracting mechanism 40. Additionally, protrusion 166 of lockingmechanism 164 returns in part within recessed portion 176 of spoolhousing 44. Thus, recessed portion 176 of spool housing 44 providessupplemental locking of locking mechanism 164.

Reference is now made to FIGS. 9A-C and 10A-D, which are schematiccross-sectional and isometric illustrations, respectively, of a rotationhandle 400, in accordance with an application of the present invention.For some applications, rotation handle 400 is used for controllingrotation tool 80, and thus the rotational positions of tubes 94, 96, and98, described hereinabove with reference to FIGS. 6A-B. Alternatively,rotation handle 400 is used to rotate other tubes, such as for othermedical applications.

Rotation handle 400 comprises a handle housing 410 and one or more knobsfor controlling the rotation of the tubes. The housing is typicallyconfigured to be coupled to outer tube 94, such that the outer tubecannot rotate with respect to the housing. The handle may comprise ahollow coupling element 412, into which the outer tube is inserted andfixed. Intermediate tubes 96 and 98 are coupled to other elements ofhandle 400, as described below.

As mentioned above, for some applications handle 400 is used withrotation tool 80. For these applications, after annuloplasty ring 22 hasbeen implanted, a proximal portion of longitudinal member 86 extendsoutside the patient's body, such as via sheath 104 (shown, for example,in FIGS. 2, 11C-I, and 12). Tubes 94, 96, and 98 are threaded over thisproximal portion of the longitudinal member, such that the longitudinalmember is directly within inner tube 98, which is in turn withinintermediate tube 96, which is in turn within outer tube 94. Theproximal end of longitudinal member 86 is threaded at least partiallythrough the handle, such as entirely through the length of handle 400,from a distal end 414 thereof to a proximal end 416 thereof.

Longitudinal member 86 is coupled to the handle such that thelongitudinal member is longitudinally fixed to the housing (i.e., cannotbe withdrawn), but is allowed to rotate with respect to the housing. Forsome applications, handle 400 comprises a longitudinal member couplingassembly 418, for example positioned in a vicinity of proximal end 416of the housing. Typically, longitudinal member coupling assembly 418 isconfigured to rotate with respect to the housing, thereby allowinglongitudinal member 86 to rotate with respect to the housing. For someapplications, longitudinal member coupling assembly 418 comprises alever 452 that is biased by a spring 454 to pivot such that an end ofthe lever at a central longitudinal axis of handle 400 applies a forcein a distal direction. The end of the level is shaped to allowlongitudinal member 86 to be advanced toward proximal end 416 of handle400, while preventing withdrawal of the longitudinal member in a distaldirection.

For some applications, rotation handle 400 comprises anintermediate-tube (second-tube) rotation knob 430 and an inner-tube(first-tube) rotation knob 432. Optionally, intermediate-tube rotationknob 430 is positioned closer to distal end 414 of handle 400 than isinner-tube rotation knob 432. Intermediate-tube rotation knob 430 iscoupled to intermediate tube 96 (e.g., using an adhesive), such thatrotation of the knob rotates the tube. Inner-tube rotation knob 432 iscoupled to inner tube 98 (e.g., using an adhesive), such that rotationof the knob rotates the tube. The two knobs thus enable convenientrotation of the tubes, either separately or together.

For some applications, rotation handle 400 further comprises a controlknob 434, which, for some applications, is configured to slidelongitudinally in distal and proximal directions over knobs 430 and 432.When control knob 434 is positioned in a first position (e.g., a firstlongitudinal position, such as a proximal position, as shown in FIGS. 9Aand 9B), an inner surface of the control knob engages both knobs 430 and432. Rotation of the control knob thus rotates both intermediate-tuberotation knob 430 (and thus intermediate tube 96) and inner-tuberotation knob 432, (and thus inner tube 98). The rotation ofintermediate tube 96 rotates spool 46, as described hereinabove withreference to FIGS. 6A-B. The rotation of inner tube 98 rotateslongitudinal member 86 at the same rate as the spool is rotated, suchthat longitudinal member 86 remains screwed into the spool. For someapplications, the inner surface of the control knob is shaped so as todefine ridges which matingly engage troughs defined by external surfacesof knobs 430 and 432.

When control knob 434 is positioned in a second position (e.g., a secondlongitudinal position, such as a distal position, as shown in FIG. 9C),(a) an inner surface of control knob 434 engages intermediate-tuberotation knob 430 but not inner-tube rotation knob 432, leaving knob 432free to rotate independently of control knob 434, and (b) an outersurface of control knob 434 engages housing 410, rotationally fixing thecontrol knob, and thus intermediate-tube rotation knob 430, to thehousing. Handle 400 thus prevents rotation of intermediate tube 96 andouter tube 94, while allowing rotation of inner tube 98. Whileintermediate tube 96 is prevented from rotating and thus preventsrotation of spool 46, rotation of inner tube 98 causes correspondingrotation of longitudinal member 86, and unscrews the longitudinal memberfrom spool 46, as described hereinabove with reference to FIGS. 6A-B.

The outer surface of control knob 434 may be shaped so as to defineridges, protrusions 440 (as best seen in FIG. 10D), teeth, or otherengagement surfaces, for engaging housing 410, an inner surface of whichmay define complementary engagement surfaces, such as troughs.

For some applications, when in the first position control knob 434 iscloser to proximal end 416 of handle 400, as shown in FIGS. 9A and 9B,and when in the second position control knob 434 is closer to distal end414 of handle 400, as shown in FIG. 9C.

For some applications, when control knob 434 is positioned in the firstlongitudinal position (such as a proximal position, as shown in FIGS.9A, 9B, and 10A-C), the control knob at least partially (typicallyentirely) covers inner-tube rotation knob 432, thereby preventing accessto knob 432 by the surgeon. When control knob 434 is subsequentlypositioned in the second longitudinal position (such as a distalposition, as shown in FIGS. 9C and 10D), the control knob reveals (i.e.,no longer covers) inner-tube rotation knob 432. The surgeon thus hasconvenient access to exposed knob 432, as best seen in FIG. 10D. Housing410 is also shaped so as to enable such access, as can be seen, forexample, in FIG. 10D.

For some applications, control knob 434 does not slide, and insteadassumes the first and second positions in response to a non-slidingmotion.

For some applications, handle 400 comprises one or more springs 460 thatspring-load one or more of tubes 94, 96, and 98, pushing the tubes in adistal direction. Such spring-loading pushes the tubes against therespective elements of contracting mechanism 40, helping the tubes toengage the respective elements of the contracting mechanism, asdescribed hereinabove with reference to FIGS. 6A-B.

For some applications, rotation handle 400 comprises a spring lockingmechanism 462, which is configured to assume locking and releasedstates. In the locking state, as shown in FIGS. 9A and 10A-B, the springlocking mechanism prevents one or more of tubes 94, 96, and 98 fromadvancing in a distal direction. For example, the mechanism may preventtubes 94, 96, and 98 from advancing distally by preventing distalmovement of coupling element 412, intermediate-tube rotation knob 430,and inner-tube rotation knob 432, respectively. Preventing such distalmovement holds the springs in relatively compressed states, and preventsthe springs from applying force to the tubes. The tubes are more easilycoupled to the respective elements of contracting mechanism 40 when thetubes are not spring-loaded.

For some applications, spring locking mechanism 462 comprises one ormore pins 464, such as three pins, which are configured to be insertedinto housing 410 (e.g., into respective openings in the housing), and,when so inserted, to block the distal motion of respective elements ofthe rotation handle, such as coupling element 412, intermediate-tuberotation knob 430, and inner-tube rotation knob 432.

In the released state, as shown in FIGS. 9B-C and 10C-D, spring lockingmechanism 462 does not prevent tubes 94, 96, and 98 from advancing inthe distal direction. For example, the mechanism may not prevent distalmovement of coupling element 412, intermediate-tube rotation knob 430,and inner-tube rotation knob 432. Releasing the tubes and/or theseelements allows springs 460 to expand, thereby pushing the tubes in adistal direction, as best seen in FIG. 9B. Such spring-loading pushesthe tubes against the respective elements of contracting mechanism 40,helping the tubes to engage the respective elements of the contractingmechanism, as described hereinabove with reference to FIGS. 6A-B.Typically, the springs distally advance the tubes 94, 96, and 98 bydistally moving coupling element 412, intermediate-tube rotation knob430, and inner-tube rotation knob 432, respectively, as shown in FIG.9B.

Reference is still made to FIGS. 10A-D. FIG. 10A shows rotation handle400 after the tubes have been coupled to respective elements of thehandle, as described above, and as the surgeon pulls longitudinal member86 through handle 400 and out of proximal end 416 thereof. As describedabove, longitudinal member coupling assembly 418 may be provided toprevent withdrawal of the longitudinal member in a distal directionafter the longitudinal member has been drawn sufficiently through thehandle. FIG. 10A also shows spring locking mechanism 462 in its lockingstate.

FIG. 10B shows rotation handle 400 after the initial coupling of thetubes to contracting mechanism 40. Because spring locking mechanism 462is still in its locking state, springs 460 have not yet distally pushedthe tubes, so the tubes have not yet fully engaged respective elementsof the contracting mechanism.

FIG. 10C shows rotation handle 400 after spring locking mechanism 462has been released to its released state. This release allows springs 460to distally push the tubes against respective elements of contractingmechanism 40 until the tubes fully engage respective elements of thecontracting mechanism. Control knob 434 is shown in its first (proximal)longitudinal position, in which an inner surface of the control knobengages both knobs 430 and 432 (not visible in FIG. 10C). Rotation ofthe control knob thus rotates both intermediate-tube rotation knob 430(and thus intermediate tube 96) and inner-tube rotation knob 432 (andthus inner tube 98). The rotation of intermediate tube 96 rotates spool46, as described hereinabove with reference to FIGS. 6A-B. The rotationof inner tube 98 rotates longitudinal member 86 at the same rate as thespool is rotated, such that longitudinal member 86 remains screwed intothe spool.

FIG. 10D shows rotation handle 400 after control knob 434 has been ispositioned in its second (distal) longitudinal position, in which (a) aninner surface of control knob 434 engages intermediate-tube rotationknob 430 (not visible in FIG. 10D) but not inner-tube rotation knob 432(visible in FIG. 10D), leaving knob 432 free to rotate independently ofcontrol knob 434, and (b) an outer surface of control knob 434 engageshousing 410, rotationally fixing the control knob, and thusintermediate-tube rotation knob 430, to the housing. Handle 400 thusprevents rotation of intermediate tube 96 and outer tube 94, whileallowing rotation of inner tube 98. While intermediate tube 96 isprevented from rotating and thus prevents rotation of spool 46, rotationof inner tube 98 causes corresponding rotation of longitudinal member86, and unscrews the longitudinal member from spool 46, as describedhereinabove with reference to FIGS. 6A-B.

Reference is now made to FIGS. 11A-I, which are schematic illustrationsof a procedure for implanting annuloplasty ring 22 to repair a mitralvalve 130, in accordance with an application of the present invention.The procedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

The procedure typically begins by advancing a semi-rigid guidewire 102into a right atrium 120 of the patient, as shown in FIG. 11A.

As show in FIG. 11B, guidewire 102 provides a guide for the subsequentadvancement of a sheath 104 therealong and into the right atrium. Oncesheath 104 has entered the right atrium, guidewire 102 is retracted fromthe patient's body. Sheath 104 typically comprises a 14-20 F sheath,although the size may be selected as appropriate for a given patient.Sheath 104 is advanced through vasculature into the right atrium using asuitable point of origin typically determined for a given patient. Forexample:

-   -   sheath 104 may be introduced into the femoral vein of the        patient, through an inferior vena cava 122, into right atrium        120, and into a left atrium 124 transseptally, typically through        the fossa ovalis;    -   sheath 104 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        120, and into left atrium 124 transseptally, typically through        the fossa ovalis; or    -   sheath 104 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 120, and into left atrium 124 transseptally,        typically through the fossa ovalis.

For some applications of the present invention, sheath 104 is advancedthrough an inferior vena cava 122 of the patient (as shown) and intoright atrium 120 using a suitable point of origin typically determinedfor a given patient.

Sheath 104 is advanced distally until the sheath reaches the interatrialseptum.

As shown in FIG. 11D, a resilient needle 106 and a dilator (not shown)are advanced through sheath 104 and into the heart. In order to advancesheath 104 transseptally into left atrium 124, the dilator is advancedto the septum, and needle 106 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently sheath 104 therethrough and intoleft atrium 124. The dilator is passed through the hole in the septumcreated by the needle. Typically, the dilator is shaped to define ahollow shaft for passage along needle 106, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 106. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum.

The advancement of sheath 104 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 106 fromwithin sheath 104, as shown in FIG. 11E.

As shown in FIG. 11F, annuloplasty ring 22 (with anchor deploymentmanipulator 24 therein) is advanced through sheath 104 into left atrium124.

As shown in FIG. 11G, distal end 51 of sleeve 26 is positioned in avicinity of a left fibrous trigone 142 of an annulus 140 of mitral valve130. (It is noted that for clarity of illustration, distal end 51 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 142 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the tip is positioned in a vicinity of a right fibroustrigone 144 of the mitral valve (configuration not shown). Furtheralternatively, the distal tip of the sleeve is not positioned in thevicinity of either of the trigones, but is instead positioned elsewherein a vicinity of the mitral valve, such as in a vicinity of the anterioror posterior commissure. For some applications, outer tube 66 of anchordeployment manipulator 24 is steerable, as is known in the catheter art,while for other applications, a separate steerable tube is provided, asdescribed hereinbelow with reference to FIG. 15 and FIG. 16 . In eithercase, the steering functionality typically allows the area near thedistal end of the deployment manipulator to be positioned with sixdegrees of freedom. Once positioned at the desired site near theselected trigone, deployment manipulator 24 deploys a first anchor 38through the wall of sleeve 26 into cardiac tissue near the trigone.

As shown in FIG. 11H, deployment manipulator 24 is repositioned alongannulus 140 to another site selected for deployment of a second anchor38. Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the sleeve is gradually pulled off (i.e., withdrawn from) thedeployment manipulator in a distal direction during the anchoringprocedure. The already-deployed first anchor 38 holds the anchored endof sleeve 26 in place, so that the sleeve is drawn from the site of thefirst anchor towards the site of the second anchor. Typically, as thesleeve is pulled off (i.e., withdrawn from) the deployment manipulator,the deployment manipulator is moved generally laterally along thecardiac tissue, as shown in FIG. 11H. Deployment manipulator 24 deploysthe second anchor through the wall of the sleeve into cardiac tissue atthe second site. Depending on the tension applied between the first andsecond anchor sites, the portion of sleeve 26 therebetween may remaintubular in shape, or may become flattened, which may help reduce anyinterference of the ring with blood flow.

For some applications, in order to provide the second and subsequentanchors, anchor driver 68 is withdrawn from the subject's body viasheath 104 (typically while leaving outer tube 66 of the deploymentmanipulator in place in the sleeve), provided with an additional anchor,and then reintroduced into the subject's body and into the outer tube.Alternatively, the entire deployment manipulator, including the anchordriver, is removed from the body and subsequently reintroduced uponbeing provided with another anchor. Further alternatively, deploymentmanipulator 24 is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time at the selected sites.

As shown in FIG. 11I, the deployment manipulator is repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 144 (or left fibrous trigone 142 if the anchoring beganat the right trigone). Alternatively, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure.

As described hereinabove with reference to FIGS. 1A and 1B and/or FIGS.6A-8 , rotation tool 80 or anchor driver 68 of deployment manipulator 24is used to rotate spool 46 of contracting mechanism 40, in order totighten ring 22. (For clarity of illustration, contracting member 30 ofring 22, although provided, is not shown in FIGS. 11A-I.) For someapplications, rotation handle 400 is used to tighten the ring, such asdescribed hereinabove with reference to FIGS. 9A-C and/or 10A-D.Alternatively, another technique is used to tighten the ring, such asdescribed hereinabove.

For some applications, sleeve 26 is filled with a material (e.g.,polyester, polytetrafluoroethylene (PTFE), polyethylene terephthalate(PET), or expanded polytetrafluoroethylene (ePTFE)) after beingimplanted. The material is packed within at least a portion, e.g., 50%,75%, or 100%, of the lumen of sleeve 26. The filler material functionsto prevent (1) formation within the lumen of sleeve 26 of clots or (2)introduction of foreign material into the lumen which could obstruct thesliding movement of contracting member 30.

For some applications, proximal end 49 of sleeve 26 is closed uponcompletion of the implantation procedure. Alternatively, the proximalend of the sleeve may have a natural tendency to close when not heldopen by deployment manipulator 24.

Reference is made to FIG. 12 , which is a schematic illustration of thedeployment of one of anchors 38 into cardiac tissue, in accordance withan application of the present invention. For these applications, one ormore (such as all) of anchors 38 are deployed from left atrium 124,through tissue of the atrial wall, and into tissue of an upper region ofthe ventricular wall 150 near the atrium. Because the tissue of theupper region of ventricular wall is thicker than that of the atrialwall, deploying the anchors into the upper region of the ventricularwall generally provides more secure anchoring. In addition, because theanchors are not deployed laterally through the atrial wall, the risk ofperforating the atrial wall is reduced.

Annuloplasty ring 22 may be advanced toward annulus 140 in any suitableprocedure, e.g., a transcatheter procedure, a percutaneous procedure, aminimally invasive procedure, or an open heart procedure (in which caseone or more elements of system 20 are typically rigid). Regardless ofthe approach, the procedure typically includes the techniques describedhereinabove with reference to FIGS. 11G-I and 12.

For some applications, following initial contraction of annuloplastyring 22 during the implantation procedure, the ring may be furthercontracted or relaxed at a later time after the initial implantation,such as between several weeks and several months after the initialimplantation.

Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, a rotation tool or anchor driver68 of deployment manipulator 24 is reintroduced into the heart and usedto contract or relax annuloplasty ring 22.

Reference is now made to FIG. 13 , which is a schematic illustration ofsystem 10 comprising a flexible pusher element 200, in accordance withan application of the present invention. Pusher element 200 aids withaccurately positioning successive anchors 38 during an implantationprocedure, such as described hereinabove with reference to FIGS. 11H and11I. For some applications, pusher element 200 is positioned partiallywithin tube 66 of deployment manipulator 24 such that a distal portion204 of pusher element 200 extends distally out of tube 66, through anopening 206 in a vicinity of a distal end of the tube (e.g., that iswithin 3 mm of the distal end, such as within 2 mm of the distal end). Aproximal portion 202 of pusher element 200 passes through outer tube 66from opening 206 to the proximal end of tube 66. Opening 206 is providedeither through a wall of the tube (as shown in FIG. 13 ), or through thedistal end of the tube (configuration not shown). Alternatively, pusherelement 200 is positioned within sleeve 26, but outside of tube 66(configuration not shown). Typically, the pusher element is elongated,and is as least as long as sleeve 26.

Pusher element 200 helps move the distal end of deployment manipulator24 from a first site of the annulus at which the deployment manipulatorhas already deployed a first anchor (e.g., anchor 38A in FIG. 13 ) to asecond site for deployment of a second anchor (e.g., anchor 38B), in adirection indicated schematically by an arrow 210. Pusher element 200 ispushed distally out of opening 206 of tube 66, so that a distal end 212of pusher element 200 engages and pushes against an interior surface ofsleeve 26, in a direction indicated schematically by an arrow 214. Theinterior surface of the sleeve may be distal end 51 of the sleeve (asshown), or the wall of the sleeve at a location between distal end 51and opening 206 (not shown). As a result, the distal end of deploymentmanipulator 24 moves in the opposite direction, i.e., as indicated byarrow 210, toward a subsequent anchoring site. The movement in thedirection of arrow 210 is generally along a line or curve defined by theportion of pusher element 200 already extended between the anchors thathave already been deployed.

For some applications, as deployment manipulator 24 is positioned atsuccessive deployment sites of the cardiac tissue, pusher element 200 isextended respective distances through opening 206, each of whichdistances is successively greater. For other applications, afterdeployment manipulator 24 is positioned at each successive deploymentsite, the pusher element is pulled back in a proximal direction, andagain extended a desired distance in a distal direction, such that thepusher element pushes again the wall of the sleeve (at a differentlocation on the wall for each successive relocation of deploymentmanipulator 24).

This technique thus aids in locating each subsequent anchoring site fordeployment manipulator 24. The pusher element may also help control thedistance between adjacent anchoring sites, because they surgeon may pushthe pusher element a known distance after deploying each anchor.

Pusher element 200 typically comprises a strip, wire, ribbon, or band,and has a cross-section that is circular, elliptical, or rectangular.Pusher element 200 typically comprises a flexible and/or superelasticmaterial, such as a metal such as nitinol, stainless steel, or cobaltchrome. Distal end 212 of pusher element 200 is dull, so that it doesnot penetrate sleeve 26. For example, the distal end may be folded back,as shown in FIG. 13 .

FIG. 14 is a schematic illustration of a pusher tube 250 applied toproximal end 49 of sleeve 26, in accordance with an application of thepresent invention. As shown in FIG. 14 , outer tube 66 is removablypositioned partially within the lumen of sleeve 26, such that outer tube66 extends out of proximal end 49 of sleeve 26 (proximal end 49 can beseen in FIG. 1B). Pusher tube 250 is configured to pass over outer tube66, such that a distal end of the pusher tube comes in contact withproximal end 49 of sleeve 26. The pusher tube 250 is held in placeagainst proximal end 49 of sleeve 26, typically by an external controlhandle, such as external control handle 346, described hereinbelow withreference to FIG. 17 , or external control handle 490, describedhereinbelow with reference to FIG. 19 . As the sleeve is pulled off(i.e., withdrawn from) outer tube 66 of the deployment manipulator in adistal direction, pusher tube 250 pushes sleeve 26 distally with respectto outer tube 66, helping withdraw the sleeve from the outer tube. Ifthe pusher tube were not provided, the wall of sleeve 26 might snag onouter tube 66 (as mentioned above, the sleeve may comprise braided orwoven fabric). In addition, if such snagging occurs, gentle pushing withthe pusher tube in the distal direction may help free the snag. For someapplications, the techniques of this application are practiced incombination with those of the application described hereinbelow withreference to FIG. 17 .

FIG. 15 is a schematic illustration of system 10 comprising a steerabletube 300, in accordance with an application of the present invention.For this application, outer tube 66 of deployment manipulator 24 is notsteerable. Instead, to provide steering functionality, deploymentmanipulator 24 comprises a separate steering tube 300, which ispositioned around at least a portion of outer tube 66. Outer tube 66,because it does not provide this steering functionality, may have asmaller diameter than in the application described hereinabove withreference to FIG. 3 . Because outer tube 66 has a smaller diameter,sleeve 26 may also have a smaller diameter than in the applicationdescribed hereinabove with reference to FIG. 3 . For some applications,the techniques of this application are practiced in combination withthose of the application described hereinabove with reference to FIG. 14. (Although in the application described with reference to FIG. 15 ,system 10 typically comprises contracting member 30, for clarity ofillustration the contracting member is not shown in the figure.)

FIG. 16 is a schematic illustration of system 10 comprising a steerabletube 320, in accordance with an application of the present invention.For this application, outer tube 66 of deployment manipulator 24 is notsteerable. Steering functionality is instead provided by separatesteering tube 320, which is positioned around at least a portion ofshaft 70 of anchor driver 68, and within outer tube 66. For someapplications, the techniques of this application are practiced incombination with those of the application described hereinabove withreference to FIG. 14 . (Although in the application described withreference to FIG. 16 , system 10 typically comprises contracting member30, for clarity of illustration the contracting member is not shown inthe figure.)

FIG. 17 is a schematic illustration of system 10 comprising a pullingwire 340, in accordance with an application of the present invention. Adistal portion 342 of pulling wire 340 is coupled to proximal end 49 ofsleeve 26, such as by passing through one or more holes near theproximal end. One or more proximal portions 344 of the pulling wire arecoupled to an external control handle 346 of system 10, which ismanipulated by the surgeon outside of the subject's body. Externalcontrol handle 346 is coupled to a proximal portion of outer tube 66,such as a proximal end of the outer tube. Optionally, a portion ofdeployment manipulator 24 (e.g., a portion of outer tube 66) which isnever inserted in sleeve 26 comprises one or more coupling elements 348,such as loops or tubes, through which pulling wire 340 passes in orderto hold the pulling wire close to the external surface of the deploymentmanipulator. (Although in the application described with reference toFIG. 17 , system 10 typically comprises contracting member 30, forclarity of illustration the contracting member is not shown in thefigure.)

Pulling wire 340 holds sleeve 26 surrounding deployment manipulator 24.The pulling wire is released in a distal direction as sleeve 26 iswithdrawn from outer tube 66 of deployment manipulator 24 in a distaldirection. The release of the sleeve allows the sleeve to gradually bewithdrawn from the outer tube 66 of deployment manipulator 24, in acontrolled manner. In FIG. 17 , the sleeve is shown partially withdrawnfrom outer tube 66, including the portion of the sleeve through whichone of anchors 38 has been deployed.

For some applications, control handle 346 is configured to releasepulling wire 340 incrementally in the distal direction, such that eachtime the wire is further released by respective set distances(typically, the distances are equal to one another). As a result, thesleeve is withdrawn from outer tube 66 of the deployment manipulator bythis set distance (or respective distances), and subsequently-deployedanchors are approximately this set distance (or respective setdistances) apart from one another. For example, the set distances may bebetween 2 mm and 15 mm, such as 4.5 mm. For some applications, thehandle comprises a control ring 350 that is coupled to proximal portions344 of the wire, and removably engages slots 352 on the handle that arespaced apart by this set distance. The slots thus set discrete positionsfor the ring and the wire. For some applications, control handle 346 isconfigured to allow control ring 350 to move only in the distaldirection during a surgical procedure. Upon completion of theimplantation procedure, in order to detach the pulling wire from thesleeve, one end of the wire may be cut or released, and the wiredetached from the sleeve by pulling on the other end of the wire.

FIGS. 18A and 18B are schematic illustrations of another configurationof pusher tube 250, described hereinabove with reference to FIG. 14 , inaccordance with an application of the present invention. As describedhereinabove with reference to FIG. 14 , pusher tube 250 passes overouter tube 66, and pushes gently in a distal direction on proximal end49 of sleeve 26. The pusher tube is held in place against proximal end49 of sleeve 26, typically by an external control handle, such asexternal control handle 346, described hereinabove with reference toFIG. 17 . As the sleeve is pulled off (i.e., withdrawn from) outer tube66 of the deployment manipulator, pusher tube 250 pushes sleeve 26distally with respect to outer tube 66, helping withdraw the sleeve fromthe outer tube. If the pusher tube were not provided, the wall of sleeve26 might snag on outer tube 66 (as mentioned above, the sleeve maycomprise braided or woven fabric). In addition, if such snagging occurs,gentle pushing with the pusher tube in the distal direction may helpfree the snag.

In the configuration shown in FIG. 18A, pusher tube 250 comprises one ormore coupling elements 456 (such as exactly one coupling element orexactly two coupling elements). The coupling elements are configured toremovably couple proximal end 49 of sleeve 26 to a distal end 458 ofpusher tube 250, thereby allowing sleeve 26 from moving distally withrespect to outer tube 66 of deployment manipulator 24 only to the extentthat pusher tube 250 is released in the distal direction, such as usingexternal control handle 490, described hereinbelow with reference toFIG. 19 .

For some applications, coupling elements 456 have a natural tendency toflex inwards (toward a central longitudinal axis of sleeve 26 thatpasses through the proximal end of the sleeve). Outer tube 66, whenpositioned within the sleeve in a vicinity of the coupling elements,pushes the coupling elements outwards (away from the centrallongitudinal axis), causing the coupling elements to engage the sleeve.For example, the coupling elements may be curved to defineoutwardly-directed ends that push against or pierce the sleeve. Suchpushing against or piercing engages the sleeve, which, as mentionedabove, may comprise braided or woven fabric.

FIG. 18B shows sleeve 26 released from coupling elements 456. Proximalwithdrawal of outer tube 66 from sleeve 26 (into or through pusher tube250) allows coupling elements 456 to assume their naturalinwardly-flexed position, thereby releasing sleeve 26 from the couplingelements, and decoupling the sleeve from the pusher tube. As describedhereinabove, sleeve 26 is gradually pulled off (i.e., withdrawn from)deployment manipulator 24, including outer tube 66, in a distaldirection during the anchoring procedure. Outer tube 66 of deploymentmanipulator 24 is proximally withdrawn completely from the sleeve at theconclusion of the anchoring procedure. The flexing of the couplingelements releases the sleeve at the conclusion of the procedure.

FIG. 19 is a schematic illustration of system 10 comprising an externalcontrol handle 490, in accordance with an application of the presentinvention. External control handle 490 is configured to be used withpusher tube 250, as described hereinabove with reference to FIGS. 14and/or 18A-B. The handle is manipulated by the surgeon outside of thesubject's body. External control handle 490 is coupled to a proximalportion of outer tube 66, such a proximal end of the outer tube. Forsome applications, coupling elements 456 of pusher tube 250 coupleproximal end 49 of sleeve 26 to distal end 458 of pusher tube 250, asdescribed hereinabove with reference to FIGS. 18A-B (proximal end 49 canbe seen in FIG. 18B). A proximal end of pusher tube 250 is coupled tohandle 490. (Although in the application described with reference toFIG. 19 , system 10 typically comprises contracting member 30, forclarity of illustration the contracting member is not shown in thefigure.)

External control handle 490 is configured to release pusher tube 250 ina distal direction as sleeve 26 is withdrawn from outer tube 66 ofdeployment manipulator 24. The release of pusher tube 250 releasessleeve 26, and allows the sleeve to gradually be withdrawn from outertube 66, in a controlled manner. In FIG. 19 , the sleeve is shownpartially withdrawn from outer tube 66, including the portion of thesleeve through which one of anchors 38 has been deployed.

For some applications, control handle 490 is configured to releasepusher tube 250 incrementally in the distal direction, such that eachtime the pusher tube is further released by respective set distances(typically, the distances are equal to one another). As a result, thesleeve is withdrawn from outer tube 66 of the deployment manipulator bythis set distance (or respective distances), and subsequently-deployedanchors are approximately this set distance (or respective distances)apart from one another. For example, the set distances may be between 2mm and 15 mm, such as 4.5 mm. For some applications, the handlecomprises control ring 350 that is coupled to a proximal end of pushertube 250, and removably engages slots 352 on the handle that are spacedapart by this set distance. The slots thus set discrete positions forthe ring and the pusher tube. For some applications, control handle 490is configured to allow control ring 350 to move only in the distaldirection during a surgical procedure. For some applications, uponcompletion of the implantation procedure, in order to detach the pushertube from the sleeve, outer tube 66 of deployment manipulator 24 isproximally withdrawn completely from the sleeve, thereby causing thecoupling elements to release the sleeve, such as described hereinabovewith reference to FIG. 18B.

Although annuloplasty ring 22 has been described hereinabove ascomprising a partial annuloplasty ring, for some applications of thepresent invention, the ring instead comprises a full annuloplasty ring.

Reference is made to FIGS. 20A-E, which are schematic cross-sectionaland isometric illustrations of a configuration of driver head 72 ofanchor driver 68, in accordance with an application of the presentinvention.

Anchor driver 68 is described hereinabove, for example, with referenceto FIG. 2 . Driver head 72 comprises an inner mating component 470,which is coupled to a distal end 472 of flexible shaft 70, such as bywelding, such that inner mating component 470 is rotationally fixed toshaft 70. (In this context, “inner” means closer to a longitudinal axis473 of driver head 72.) As shown in FIGS. 20B and 20D, a distal end ofinner mating component 470 is shaped so as to define one or more (e.g.,two) mechanical coupling elements, such as protrusions 474. Couplinghead 74 of anchor 38 is shaped so as to define corresponding matingelements, such as slots 476, also shown in FIG. 20B. Before implantationof anchor 38, coupling head 74 is removably coupled to inner matingcomponent 470 by the coupling and mating elements.

Driver head 72 further comprises an outer element 478, which at leastpartially surrounds inner mating component 470 and extends in a distaldirection beyond a distal end of inner mating component 470. (In thiscontext, “outer” means further from longitudinal axis 473 of driver head72.) Typically, outer element 478 is free to rotate with respect toinner mating component 470. Outer element 478 is typicallylongitudinally fixed to the inner mating component. For example, theinner mating component may be shaped so as to define at least onelateral protrusion 480, and the outer element may be shaped to define atleast one corresponding recess 482. Alternatively, one or more of innermating component 470, distal end 472 of flexible shaft 70, and outerelement 478 are welded together, or comprise a single element.

An outer surface of coupling head 74 of anchor 38 is typically shaped soas to define a screw thread 484. The screw thread is initially screwedinto a flexible ring 486 that is coupled to an inner surface of outerelement 478. The ring is sized to tightly engage the screw thread. Thering may comprise, for example, silicone, rubber, or a springy metal.For some applications, a distal portion of coupling head 74 (such as theportion that defines screw thread 484) is conical.

During deployment of anchor 38 into tissue, such as describedhereinabove with reference to FIGS. 2, 3, 11G-H, 12, 13, 14, 15, and/or16, rotation of shaft 70 and inner mating component 470 causescorresponding rotation of anchor 38. As tissue coupling element 76 ofanchor 38 rotates, the tissue coupling element screws itself into thetissue, thereby advancing itself in a distal direction (to the right inFIG. 20C) into the tissue. This rotation and distal advancement of theanchor unscrews screw thread 484 from flexible ring 486, and, at thesame time, separates the mating elements of coupling head 74 of theanchor from the coupling elements of inner mating component 470 ofdriver head 72.

This configuration of driver head 72 and anchor 38 thus enables theanchor to self-disconnect from the driver head.

For some applications, anchor 38 is coupled to driver head 72 (typicallyduring manufacture) by:

-   -   aligning protrusions 474 with slots 476;    -   holding inner mating component 470 and tissue coupling element        76 rotationally stationary; and    -   rotating outer element 478, which causes flexible ring 486 to        screw in screw thread 484 of coupling head 74. As the coupling        head is screwed into driver head 72, protrusions 474 enter slots        476.

Reference is now made to FIG. 21 , which is a schematic illustration ofan implant structure 500 comprising repair chords 510, in accordancewith an application of the present invention. In this application,repair chords 510 function as artificial chordae tendineae, and compriseone or more longitudinal members 520 and 522, e.g., sutures, wires, orelongate tensioning coils, which are coupled at respective first endportions thereof to a contracting mechanism 512. Respective second endportions of the longitudinal members are coupled (e.g., tied, sutured,clipped, or otherwise fastened) to a second portion of tissue whichfaces and surrounds the ventricle, such as a leaflet 552 of anatrioventricular valve 554 (e.g., a mitral valve or a tricuspid valve).Longitudinal members 520 and 522 are knotted together using at least onesuture knot 523, and excess portions of longitudinal members 520 and 522are cut away from the knot. Alternatively, any suitable anchor may beused instead of the knot. For example, longitudinal member 520 maycomprise a male clip at its free end and longitudinal member 522 maycomprise a female clip at its free end. In this case, longitudinalmembers 520 and 522 are clipped at their free ends to the leaflet. Forsome applications, anchors or clips may be used that are described inU.S. patent application Ser. No. 12/548,991, filed Aug. 27, 2009, whichpublished as US Patent Application Publication 2010/0161042 and isincorporated herein by reference, such as with reference to one or moreof FIGS. 9A-18D and 22A-23I thereof.

Implant structure 500 comprises a contracting mechanism assembly 514,which comprises contracting mechanism 512 and a tissue anchor 550. Thetissue anchor facilitates implantation of the contracting mechanismassembly in a first portion of tissue of the heart which faces andsurrounds the ventricular lumen, such as a papillary muscle 518. Tissueanchor 550 is shown as a helical anchor by way of illustration and notlimitation, and may comprise staples, clips, spring-loaded anchors, orother tissue anchors known in the art. Alternatively, contractingmechanism assembly 514 does not include tissue anchor 50 and is,instead, sutured to a portion of tissue of a ventricle wall which facesa ventricular lumen of a heart of a patient.

For some applications, contracting mechanism 512 comprises a rotatablestructure, such as a spool (not visible in FIG. 21 , but typicallysimilar to spool 46, described hereinabove with reference to FIGS. 5A-B,6A-B, 7, and 8), and, typically, a housing 516, which houses the spool.First end portions of the longitudinal members are coupled tocontracting mechanism 512, typically to spool 46.

Implant structure 500 comprises one or more longitudinal members 86,which are coupled to contracting mechanism 512, such as to housing 516or to the spool. A rotation tool 530 is configured to pass overlongitudinal members 86, engage the spool of contracting mechanism 512,and rotate the spool, thereby tightening the contracting mechanism, andshortening and tensioning longitudinal members 520 and 522.

For some applications, implant structure 500 utilizes techniquesdescribed hereinabove with reference to FIGS. 5A-B, 6A-B, 7, 8, 9A-C,and/or 10A-D. For some applications, implant structure 500 utilizestechniques described in U.S. patent application Ser. No. 12/548,991,filed Aug. 27, 2009, which is incorporated herein by reference, such aswith reference to one or more of FIGS. 3-18D and 22A-23I thereof.

Reference is made to FIGS. 22A and 22B, which are schematicillustrations of another implant structure 600 comprising repair chords510, in accordance with respective applications of the presentinvention. In these application, repair chords 510 are used to adjust adistance between two portions of the ventricular wall.

FIG. 22A shows implant structure 600 comprising contracting mechanismassembly 514 implanted at a first portion 620 of heart tissue whichfaces and surrounds the left ventricle of the heart. The free ends oflongitudinal members 520 and 522 are coupled to a second portion 622 ofheart tissue which faces and surrounds the left ventricle, e.g., at theseptum, by way of illustration and not limitation. The free ends oflongitudinal members 520 and 522 are coupled to the heart tissue usingany suitable attachment means 602, e.g., sutures, knotting, or tissueanchors such as helical anchors.

Implant structure 600 comprises contracting mechanism assembly 514,described hereinabove with reference to FIG. 20 . Implant structure 600comprises one or more longitudinal members 86, which are coupled tocontracting mechanism 512, such as to housing 516 or to the spool.Rotation tool 530 is configured to pass over longitudinal members 86,engage the spool of contracting mechanism 512, and rotate the spool,thereby tightening the contracting mechanism, and shortening andtensioning longitudinal members 520 and 522. In response to theshortening of longitudinal members 520 and 522, first and secondportions 620 and 622 of the heart tissue are pulled toward one another.Consequently, the dimensions of the heart wall are restored tophysiological dimensions, and the leaflets are drawn toward one another.

FIG. 22B shows implant structure 700 for adjusting a distance betweentwo portions of a heart wall of the left ventricle of the patient.Longitudinal members 520 and 522 are coupled at first portions thereofto a rotatable structure, e.g., a spool, of contracting mechanism 512.Respective free ends of each member 520 and 522 are coupled to opposingfirst and second portions of the heart wall which faces and surroundsthe ventricular lumen of the heart. The free end of longitudinal member522 is coupled to first implantation site using a first helical anchor750 by way of illustration and not limitation. For example, the free endof longitudinal member 522 is coupled to the first implantation siteusing sutures, knots, or any tissue anchor known in the art. The freeend of longitudinal member 520 is coupled to a second implantation siteusing a second helical anchor 750 by way of illustration and notlimitation. For example, the free end of longitudinal member 520 iscoupled to the second implantation site using sutures, knots, or anytissue anchor known in the art. In such a configuration, contractingmechanism 512 is disposed between longitudinal members 520 and 522 andis not directly coupled to heart tissue.

Following the attaching of longitudinal members 520 and 522 to the firstand second implantation sites, respectively, rotation tool 530 is passedover longitudinal members 86, and used to rotate the spool ofcontracting mechanism 512, such as described hereinabove. As describedhereinabove, using tool 530, the spool of contracting mechanism 512 isrotated in order to adjust a distance between the first and secondimplantation sites. Responsively, the first and second portions of theventricle wall are drawn together. Consequently, the dimensions of theheart wall are restored to physiological dimensions, and the leafletsare drawn toward one another.

For some applications, implant structure 500 utilizes techniquesdescribed hereinabove with reference to FIGS. 5A-B, 6A-B, 7, 8, 9A-C,and/or 10A-D. For some applications, implant structure 500 utilizestechniques described in U.S. patent application Ser. No. 12/548,991,filed Aug. 27, 2009, which is incorporated herein by reference, such aswith reference to one or more of FIGS. 19-21 thereof.

Reference is made to FIG. 23 , which is a schematic illustration ofanother configuration of contracting mechanism 40 and an implantstructure 800, in accordance with an application of the presentinvention. In this application, contracting mechanism 40 is used toadjust a length or circumference of implant structure 800, which maycomprise, for example, a partial or a full annuloplasty ring, such asring 22, or another implant structure. In this application, a firstrotatable structure 810 is shaped so as to define a pinion 812, and afirst portion 813 of implant structure 800 is shaped so as to define arack 814. Geared teeth of pinion 812 matingly engage teeth of rack 814,such that first portion 813 passes between first rotatable structure 810and a second rotatable structure 816 that rotates on an axel 818 that iscoupled to a second portion 820 of implant structure 800. The first andsecond rotatable structures 810 and 816 are maintained at an appropriatedistance from each other using a housing or bracket. (For clarity ofillustration, the housing or bracket is not shown in the figure, becausethe housing or bracket is typically positioned on the further side ofthe rotatable structures that is not visible in the figure.) Forexample, the housing or bracket may connect the axels of the rotatablestructures on the sides thereof opposite the sides shown in FIG. 23 .Alternatively, for some applications, second rotatable structure 816 isnot provided, and first rotatable structure 810 is coupled directly tosecond portion 820 of implant structure 800.

For applications in which implant structure 800 comprises a full band,such as a full annuloplasty ring, the first and second portions 813 and820 of implant structure 800 are opposite ends of the same continuousstructure. For applications in which implant structure comprises apartial band, such as a partial annuloplasty ring, the respectiveportions of first and second portions 813 and 820 are coupled nearrespective ends of a sleeve, or themselves define the ring.

Implant structure 800 comprises longitudinal member 86, which is coupledto contracting mechanism 40. Rotation tool 80 is provided for rotatingfirst rotatable structure 810. The tool is configured to be guided overthe longitudinal member, to engage the rotatable structure, and torotate the rotatable structure in response to a rotational force appliedto the tool, such as using techniques described hereinabove withreference to FIGS. 5A-B, 6A-B, 7, 8, 9A-C, and/or 10A-D.

Reference is made to FIGS. 24A-B and 25, which are schematicillustrations of a valve prosthesis assembly 900, in accordance with anapplication of the present invention. Valve prosthesis assembly 900comprises a prosthetic heart valve 910 that is couplable to a base ring922. Prosthetic heart valve 910 is used to replace a native diseasedheart valve. Valve 910 comprises a plurality of artificial leaflets 930,which comprise a pliant material. Valve 910 may implement techniquesknown in the artificial valve art, such as described, for example, in USPatent Application Publication 2007/0255400 to Parravicini et al., USPatent Application Publication 2004/0122514 to Fogarty et al., US PatentApplication Publication 2007/0162111 to Fukamachi et al., and/or USPatent Application Publication 2008/0004697 to Lichtenstein et al., allof which are incorporated herein by reference.

Valve 910 further comprises an annular base 932, to which artificialleaflets 930 are coupled. Annular base 932 is configured to be couplableto base ring 922 during an implantation procedure. For example, as showin FIG. 25 , base ring 922 may comprise one or more coupling elements934, such as clips or magnets, which are configured to be coupled tocorresponding coupling elements on a lower surface of annular base 932(not visible in the figures). Alternatively or additionally, annularbase 932 may be configured to be placed within the opening defined bybase ring 922, as shown in FIG. 24A. To hold the annular base coupled tothe base ring, the base ring is tightened around the annular base, asshown in FIG. 24B, typically using one or more of the techniquesdescribed hereinabove for contracting implant structures. Typically,valve prosthesis assembly 900, such as annular base 932 thereof, isconfigured to push and hold open the intact diseased native leaflets.

Base ring 922 implements one or more of the techniques of annuloplastyring 22 described hereinabove. In particular, base ring 922 may becoupled to the annulus of the native diseased valve using the anchoringtechniques described hereinabove. In addition, base ring 922 typicallycomprises a rotatable structure 936, such as a spool, which is typicallyimplemented using techniques described herein. The rotatable structureis arranged such that rotation thereof contracts base ring 922,typically using techniques described herein. Such tightening may serveto couple base ring 922 to annular base 932, as shown in FIG. 24B.Alternatively or additionally, such tightening sets the desireddimensions of the base ring, in order to align the coupling elements ofthe base ring with those of valve 910, thereby enabling tight coupling,such as for the applications described with reference to FIG. 25 .

For some applications, base ring 922 comprises a partial ring, as shownin FIG. 25 , while for other applications, the base ring comprises afull ring, as shown in FIGS. 24A-B.

Valve prosthesis assembly 900 is typically implanted in a minimallyinvasive transcatheter or percutaneous procedure. The procedure beginswith the introduction and implantation of base ring 922 into the heart,such as using techniques for implanting annuloplasty ring 22, describedhereinabove with reference to FIGS. 11A-I. Prosthetic heart valve 910 issubsequently introduced into the heart and coupled to base ring 922, asdescribed above. Valve prosthesis assembly 900 is typically used forreplacement of a diseased native mitral valve, aortic valve, tricuspidvalve, or pulmonary valve.

For some applications of the present invention, system 20 is used totreat an atrioventricular valve other than the mitral valve, i.e., thetricuspid valve. For these applications, annuloplasty ring 22 and othercomponents of system 20 described hereinabove as being placed in theleft atrium are instead placed in the right atrium. Althoughannuloplasty ring 22 is described hereinabove as being placed in anatrium, for some application the ring is instead placed in either theleft or right ventricle.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section of the present patent application.

Additionally, the scope of the present invention includes applicationsdescribed in the following applications, which are incorporated hereinby reference. In an application, techniques and apparatus described inone or more of the following applications are combined with techniquesand apparatus described herein:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed on Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as PCT Publication WO 08/068756;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as US Patent Application Publication        2008/0262609;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 16, 2008;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008, which published as US Patent Application        Publication 2010/0161047;    -   U.S. Provisional Patent Application 61/207,908 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2009;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US Patent        Application Publication 2010/0161041;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US Patent Application        Publication 2010/0286767;    -   PCT Patent Application PCT/IL2009/000593 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 15, 2009 which published as PCT        Publication WO 10/004546;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as US Patent Application        Publication 2010/0161042;    -   U.S. patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty ring,” filed on Oct.        29, 2009, which published as US Patent Application Publication        2011/0106247;    -   U.S. Provisional Patent Application 61/265,936 to Miller et al.,        entitled, “Delivery tool for implantation of spool assembly        coupled to a helical anchor,” filed Dec. 2, 2009;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009, which published as PCT        Publication WO 10/073246;    -   U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010,        which published as US Patent Application Publication        2010/0280604;    -   U.S. patent Ser. No. 12/689,693 to Hammer et al., entitled,        “Deployment techniques for annuloplasty ring,” filed on Jan. 19,        2010, which published as US Patent Application Publication        2010/0280605; and/or    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2010,        which published as US Patent Application Publication        2010/0211166.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A method for use with an atrioventricularvalve of a heart of a subject, the method comprising: advancing acatheter transfemorally to the atrium; using a transfemoral anchordriver, while a distal head of the anchor driver is engaged with acoupling head of a first anchor of an elongate annuloplasty structure:advancing the first anchor into an atrium of the heart; and within theatrium, anchoring a first part of the annuloplasty structure to anannulus of the valve by screwing a tissue-coupling element of the firstanchor into a first site of the annulus: while a shaft of the anchordriver extends through the catheter to the atrium, and a second part ofthe annuloplasty structure remains disposed within the catheter, andsuch that the tissue-coupling element of the first anchor enters cardiactissue at the first site in a direction parallel to a centrallongitudinal axis of the anchor driver through the distal end of theanchor driver; subsequently, decoupling the distal head of the anchordriver from the coupling head of the first anchor, and retracting theanchor driver out of the heart; subsequently, using the anchor driver,while the distal head of the anchor driver is engaged with a couplinghead of a second anchor of the annuloplasty structure: advancing thesecond anchor into the atrium; and within the atrium, anchoring thesecond part of the annuloplasty structure to the annulus by screwing atissue-coupling element of the second anchor into a second site of theannulus: while the shaft of the anchor driver extends through thecatheter to the atrium, and a third part of the annuloplasty structureremains disposed within the catheter, and such that the tissue-couplingelement of the second anchor enters cardiac tissue at the second site ina direction parallel to the central longitudinal axis of the anchordriver through the distal end of the anchor driver; subsequently,decoupling the distal head of the anchor driver from the coupling headof the second anchor, and retracting the anchor driver out of the heart;subsequently, using the anchor driver, while the distal head of theanchor driver is engaged with a coupling head of a third anchor of theannuloplasty structure: advancing the third anchor into the atrium; andwithin the atrium, anchoring the third part of the annuloplastystructure to the annulus by screwing a tissue-coupling element of thethird anchor into a third site of the annulus, such that thetissue-coupling element of the third anchor enters cardiac tissue at thethird site in a direction parallel to the central longitudinal axis ofthe anchor driver through the distal end of the anchor driver; andsubsequently, treating the valve by reducing a distance between thefirst site and the second site, and a distance between the second siteand the third site, by tightening a flexible and elongate contractingmember of the annuloplasty structure.
 2. The method according to claim1, wherein screwing the tissue- coupling element of the second anchorinto the second site comprises screwing the tissue- coupling element ofthe second anchor into the second site while the central longitudinalaxis of the anchor driver through the distal end of the anchor driverforms an angle of between 45 and 90 degrees with a line defined betweenthe first site and the second site.
 3. The method according to claim 2,wherein screwing the tissue- coupling element of the third anchor intothe third site comprises screwing the tissue-coupling element of thethird anchor into the third site while the central longitudinal axis ofthe anchor driver through the distal end of the anchor driver forms anangle of between 45 and 90 degrees with a line defined between thesecond site and the third site.
 4. The method according to claim 1,wherein screwing the tissue- coupling element of the second anchor intothe second site comprises screwing the tissue-coupling element of thesecond anchor into the second site while a portion of the contractingmember extends, alongside the anchor driver, proximally away from thesecond site.
 5. The method according to claim 1, wherein the cathetercomprises steering functionality, and wherein the method furthercomprises using the steering functionality to direct, toward the secondsite, the anchor driver coupled to the second anchor.
 6. The methodaccording to claim 1, wherein the method further comprises advancing asheath transfemorally to the atrium, and wherein advancing the cathetertransfemorally to the atrium comprises advancing the cathetertransfemorally through the sheath to the atrium.
 7. The method accordingto claim 1, wherein the first site is in a vicinity of a left fibroustrigone of the heart, and wherein screwing the tissue-coupling elementof the first anchor into the first site comprises screwing thetissue-coupling element of the first anchor into the first site that isin the vicinity of the left fibrous trigone of the heart.
 8. The methodaccording to claim 1, wherein the first site is in a vicinity of a rightfibrous trigone of the heart, and wherein screwing the tissue-couplingelement of the first anchor into the first site comprises screwing thetissue-coupling element of the first anchor into the first site that isin the vicinity of the right fibrous trigone of the heart.
 9. The methodaccording to claim 1, wherein the first site is in a vicinity of acommissure of the valve, and wherein screwing the tissue-couplingelement of the first anchor into the first site comprises screwing thetissue-coupling element of the first anchor into the first site that isin the vicinity of the commissure of the valve.
 10. The method accordingto claim 1, wherein the contracting member comprises a plurality ofwires that are intertwined to form a rope structure.
 11. The methodaccording to claim 1, wherein the contracting member comprises at leastone of stainless steel, nitinol, and cobalt chrome.
 12. The methodaccording to claim 1, further comprising, subsequently to tightening thecontracting member, locking a lock to maintain tautness in thecontracting member.
 13. The method according to claim 1, wherein theatrioventricular valve is a mitral valve of the heart, and whereintreating the valve comprises treating the mitral valve of the heart. 14.The method according to claim 1, wherein the atrioventricular valve is atricuspid valve of the heart, and wherein treating the valve comprisestreating the tricuspid valve of the heart.
 15. A method for use with anatrioventricular valve of a heart of a subject, the method comprising:using a transfemoral anchor driver, while a distal end of the anchordriver is engaged with a first anchor of an elongate annuloplastystructure: advancing the first anchor into an atrium of the heart; andwithin the atrium, anchoring a first part of the annuloplasty structureto an annulus of the valve by screwing a tissue-coupling element of thefirst anchor into a first site of the annulus: while a shaft of theanchor driver extends through the catheter to the atrium, and a secondpart of the annuloplasty structure remains disposed within the catheter,and such that the tissue-coupling element of the first anchor enterscardiac tissue at the first site; subsequently, decoupling the distalend of the anchor driver from the first anchor, and retracting thedistal end of the anchor driver out of the heart; subsequently, usingthe anchor driver, while the distal end of the anchor driver is engagedwith a second anchor of the annuloplasty structure: advancing the secondanchor into the atrium; and within the atrium, anchoring the second partof the annuloplasty structure to the annulus by screwing atissue-coupling element of the second anchor into a second site of theannulus: while the shaft of the anchor driver extends through thecatheter to the atrium, and a third part of the annuloplasty structureremains disposed within the catheter, and such that the tissue-couplingelement of the second anchor enters cardiac tissue at the second site;subsequently, decoupling the distal end of the anchor driver from thesecond anchor, and retracting the distal end of the anchor driver out ofthe heart; subsequently, using the anchor driver, while the distal endof the anchor driver is engaged with a third anchor of the annuloplastystructure: advancing the third anchor into the atrium; and within theatrium, anchoring the third part of the annuloplasty structure to theannulus by screwing a tissue-coupling element of the third anchor into athird site of the annulus, such that the tissue-coupling element of thethird anchor enters cardiac tissue at the third site; and subsequently,treating the valve by reducing a distance between the first site and thesecond site, and a distance between the second site and the third site,by tightening a flexible and elongate contracting member of theannuloplasty structure.
 16. The method according to claim 15, whereinscrewing the tissue-coupling element of the second anchor into thesecond site comprises screwing the tissue-coupling element of the secondanchor into the second site while a portion of the contracting memberextends, alongside the anchor driver, proximally away from the secondsite.
 17. The method according to claim 15, wherein the first site is ina vicinity of a commissure of the valve, and wherein screwing thetissue-coupling element of the first anchor into the first sitecomprises screwing the tissue-coupling element of the first anchor intothe first site that is in the vicinity of the commissure of the valve.18. The method according to claim 15, further comprising, subsequentlyto tightening the contracting member, locking a lock to maintaintautness in the contracting member.